Spinal fixation systems
Tiger / Tiger 2 / Tiger OCT ↗
Current CoreLink-origin fixation family including posterior, MIS and OCT offerings. [224]
FDA-clearedCompanies / Zavation
Medical device company profile
Zavation
Privately held spine-device manufacturer with a distributor-led commercial model and acquired CoreLink and ChoiceSpine portfolios.
Private manufacturer · Gemspring portfolio companyOrthopedics & MusculoskeletalSpineCommercial stage
Company overview
Zavation Medical Products is a privately held manufacturer of spinal implants, interventional spine products and biologics, headquartered in Flowood, Mississippi, with a St. Louis-area facility. Current company announcements give 2012 as its founding year. Its portfolio spans cervical and lumbar interbodies, posterior fixation, SI joint fusion, vertebral augmentation and bone graft products.
Zavation is backed by Gemspring Capital and emphasizes distributor support, product training and in-house manufacturing. It acquired Pan Medical U.S. in 2018, CoreLink in 2023 and ChoiceSpine in February 2026. ChoiceSpine continues to operate under its own brand. Current-family regulatory records therefore include original Zavation, CoreLink, ChoiceSpine and Expanding Orthopedics applicant names, with pre-acquisition decisions identified.
Recent releases include Varisync ALIF and NanoPrime/Labyrinth cervical offerings. The company reported a Varisync first case at Hartford Hospital; that is a company-attributed use, not proof of system-wide adoption. Materials testing and surgeon feedback should not be treated as comparative clinical outcomes. This profile records two terminated recall events associated with current families and does not repeat historical zero-recall marketing as a current group-wide claim. Revenue, deal values and confirmed payer coverage were not established in this review.
Leadership
7 peopleDerek KuyperChief Executive Officer [222]
Ty PulliamChief Financial Officer · Head of Business Services [222]
Brad RisherChief Commercial Officer [222]
Lawrence WalkerChief Research & Development Officer [222]
Steve GordonChief Quality Officer [222]
John FutrellVice President · Specialty Spine [222]
Brett SmithVice President · Marketing [222]
Products & regulatory status How does MedTechIndex get this information?
Summary
The expanded group combines original Zavation devices with CoreLink, ChoiceSpine and acquired FLXfit families. FDA applicant names remain as filed; an older decision can belong to a current family without every historical model still being marketed. Preclinical performance, product launch and FDA marketing authorization are separate facts. The FDA decision/recall searches are completed for the named company and acquired applicants. Some supplier-origin biologic/cement and legacy records are not linked to a selected current commercial family. [221][227][218][213][114][48][225][228][2]
The matched FDA history contains 2 distinct recall events: 0 open, 2 terminated. 1 were initiated during the five years beginning October 20, 2021; older open events are also retained. Z-0954-2023 (2022-10-20; terminated): Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy. Z-1700-2021 (2021-03-25; terminated): Products distributed as sterile may not have been adequately sterilized [202][131][132][133][134][135][136][137][138][139][140][141][142][143][144][145][146][147][148][149][150][151][152][153][154][155][156][157][158][159][160][161][162][163][164][165][166][167][168][169][170][171][172][173][174][175][176][177][178][179][180][181][182][183][184][185][186][187][188][189][190][191][192][193][194][195][196][197][198][199][200][201]
Regulatory snapshot How to read this snapshot
U.S. FDA- 110
- 510(k) clearances
- 0
- De Novo grants
- 0
- PMA approvals
- 2
- Recall events
Latest recorded source review: 2026-10-20.
Commercial portfolio snapshot
Documented commercial product families.
Spinal fixation systems
Zavation Spinal / Connector systems ↗
Current Zavation posterior fixation family and associated connection hardware. [221]
FDA-clearedInterbody implants
Zavation / CoreLink interbody systems ↗
Current families include IBF/Whitney, Ti3Z, Labyrinth/NanoPrime, eZspand, Varisync, F3D, CL5 and M3. Shared-family decisions counted once. [221]
FDA-clearedAnterior cervical plates
Cervical plates · Zavation / Anodyne / Terrace / EZ ↗
Current cervical plating families listed in the IFU catalog. [221]
FDA-clearedNavigated surgical instruments
Zavation / CoreLink navigation instruments ↗
Current compatible instruments documented in IFUs; platform compatibility is not itself a commercial partnership. [226]
FDA-clearedKyphoplasty instruments and kits
ZVplasty vertebral augmentation ↗
Current vertebral augmentation family. One terminated recall event spans current-family and unresolved legacy product rows. [225]
FDA-clearedView 18 additional documented product families
Cervical interbody system
Z-Link Cervical ↗
Current cervical family; exact stand-alone criteria depend on labeling. [221]
FDA-clearedLumbar plating
Z-Span / associated lumbar plating ↗
Current static and expandable plate family. [221]
FDA-clearedLumbar plating
ZOU / Oro lumbar plates ↗
Current CoreLink-origin anterior/lateral plate families. [221]
FDA-clearedVertebral body replacement
Normandy / F3D VBR ↗
Current cervical and thoracolumbar corpectomy families. [221]
FDA-clearedSI joint fusion
Sacroiliac fixation · Siber / Entasis / SI Screw ↗
Current SI family includes acquired CoreLink-origin systems and Zavation SI Screw. [223]
FDA-clearedGraft materials
Biologics · UniFuZe / allografts ↗
Current synthetic and collagen graft offerings plus allografts. Tissue supplier and pathway mapping is incomplete; do not treat all products as cleared or exempt. [221]
Marketed · regulatory scope variesExpandable interbody implants
FLXfit / FLXfit15 ↗
Expanding Orthopedics-origin technology acquired by CoreLink in 2018, then into Zavation's group in 2023. FLXfit15 is currently listed. [214]
FDA-clearedPosterior cervical and laminoplasty fixation
ChoiceSpine Blackbird / HLS ↗
Current ChoiceSpine family retained under the ChoiceSpine brand. [209]
FDA-clearedThoracolumbar and facet fixation
ChoiceSpine Thunderbolt / Lancer / Proliant / Typhoon ↗
Current ChoiceSpine fixation families. [211]
FDA-clearedCervical interbody implants
ChoiceSpine cervical spacers ↗
Current Blackhawk Ti, Tomcat, Ascendant, Stealth and TigerShark C offerings; historical family decisions do not establish continued sale of every prior model. [209]
FDA-clearedAnterior cervical plates
ChoiceSpine cervical plates ↗
Current Boomerang, Falcon and Ambassador families. [209]
FDA-clearedLumbar interbody implants
ChoiceSpine lumbar interbodies ↗
Current TigerShark, Harrier, Octane, Shark, Harpoon and VEO families. [210]
FDA-clearedCommercial development
Recent material-platform and product releases are treated as commercial activity where documented. A separately verified, complete development pipeline was not established; unlinked historical clearances do not automatically become active development programs. [229][228]
Activity & Milestones
7 events2026-02-26 · Acquisition / Leadership
ChoiceSpine acquired; Derek Kuyper named CEO
ChoiceSpine retained its brand and operations under common ownership. Derek Kuyper was appointed CEO of the combined organization; transaction terms were undisclosed. [227]
2026-02-11 · Product launch
NanoPrime / Labyrinth cervical release
Company reported its combined implant-material release. Preclinical surface and bone-growth findings do not establish human comparative superiority. [229]
2024-09-10 · Commercialization
Varisync ALIF launch announced
Company announcement reported first clinical use in August 2024 by Hanbing Zhou at Hartford Hospital. A reported first case is not an audited hospital-wide adoption count. [228]
2023-06-26 · Acquisition
CoreLink acquired
Zavation announced the CoreLink acquisition from The Stephens Group, adding spinal implant and manufacturing capabilities. Earlier CoreLink and Expanding Orthopedics records retain original attribution. [218]
2022-10-20 · Safety history
FLXfit15 recall initiated before CoreLink acquisition
FDA event 91109 involved specific lots of FLXfit15 with a potential incorrect internal material. The event was terminated August 20, 2024; it is not an open recall. [216]
2018-09-18 · Acquisition
Pan Medical U.S. acquisition announced
Zavation and LongueVue announced the transaction with Pan Medical U.S. management, expanding vertebral augmentation. Do not assume ownership of every Pan Medical Ltd. FDA record. [217]
2012 · Company history
Company-reported founding
Current company announcements identify 2012 as founding. Earlier FDA applicant records exist; legal-formation versus commercial-launch dates require confirmation. [227]
229 Cited Sources
Accessed 10/20/2026
229 Cited Sources
Accessed 10/20/2026
[1] FDA 510(k) database — research search ↗U.S. FDA / openFDA · regulatory database
[2] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record
[3] FDA 510(k) database — research search ↗U.S. FDA / openFDA · regulatory database
[4] FDA K073440 — FOUNDATION CAGE ↗U.S. Food and Drug Administration · regulatory record
[5] FDA K073669 — ORIA NATURA SPACER ↗U.S. Food and Drug Administration · regulatory record
[6] FDA K083825 — EOI SPINAL SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[7] FDA K091531 — CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER ↗U.S. Food and Drug Administration · regulatory record
[8] FDA K091926 — CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[9] FDA K102204 — CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[10] FDA K110321 — TIGER SPINE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[11] FDA K112484 — ZAVATION SPINAL SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[12] FDA K112533 — ZAVATION CERVICAL PLATE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[13] FDA K112664 — ZAVATION IBF SYSTEMS ↗U.S. Food and Drug Administration · regulatory record
[14] FDA K113058 — TIGER SPINE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[15] FDA K120570 — CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[16] FDA K120576 — ZAVATION IBF SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[17] FDA K120696 — TIGER SPINE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[18] FDA K121514 — ANODYNE ANTERIOR CERVICAL PLATE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[19] FDA K121728 — TIGER SPINE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[20] FDA K121791 — ZOU ANTERIOR LUMBAR PLATE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[21] FDA K121850 — Typhoon(TM) Facet Screw Fixation System ↗U.S. Food and Drug Administration · regulatory record
[22] FDA K130030 — ZAVATION CERVICAL PLATE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[23] FDA K131250 — TIGER SPINE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[24] FDA K132049 — THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS ↗U.S. Food and Drug Administration · regulatory record
[25] FDA K132504 — TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[26] FDA K132620 — INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL ↗U.S. Food and Drug Administration · regulatory record
[27] FDA K132994 — ANODYNE ANTERIOR CERVICAL PLATE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[28] FDA K133214 — BLACKBIRD SPINAL SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[29] FDA K133369 — TIGER SPINE SYSTEM ↗U.S. Food and Drug Administration · regulatory record
[30] FDA K133813 — FLXFIT INTERVERTEBRAL BODY FUSION DEVICE ↗U.S. Food and Drug Administration · regulatory record
[31] FDA K140142 — CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) ↗U.S. Food and Drug Administration · regulatory record
[32] FDA K141005 — Z-LINK CERVICAL ↗U.S. Food and Drug Administration · regulatory record
[33] FDA K141419 — ZVPLASTY ↗U.S. Food and Drug Administration · regulatory record
[34] FDA K142271 — Zavation Z-Link Lumbar ↗U.S. Food and Drug Administration · regulatory record
[35] FDA K142392 — Zavation Posterior LEIF ↗U.S. Food and Drug Administration · regulatory record
[36] FDA K150322 — InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) ↗U.S. Food and Drug Administration · regulatory record
[37] FDA K150847 — Foundation Interbody Devices ↗U.S. Food and Drug Administration · regulatory record
[38] FDA K152237 — The Entasis Dual-Lead Sacroiliac Implant ↗U.S. Food and Drug Administration · regulatory record
[39] FDA K152515 — TOMCAT Cervical Spinal System ↗U.S. Food and Drug Administration · regulatory record
[40] FDA K153107 — Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System ↗U.S. Food and Drug Administration · regulatory record
[41] FDA K153404 — Zavation Spinal System ↗U.S. Food and Drug Administration · regulatory record
[42] FDA K160362 — Z-Span Plate System ↗U.S. Food and Drug Administration · regulatory record
[43] FDA K160775 — Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems ↗U.S. Food and Drug Administration · regulatory record
[44] FDA K161016 — Z-Clamp ISP System ↗U.S. Food and Drug Administration · regulatory record
[45] FDA K162103 — Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye) ↗U.S. Food and Drug Administration · regulatory record
[46] FDA K162206 — Zavation IBF ↗U.S. Food and Drug Administration · regulatory record
[47] FDA K162453 — 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) ↗U.S. Food and Drug Administration · regulatory record
[48] FDA K162496 — Foundation 3D Interbody ↗U.S. Food and Drug Administration · regulatory record
[49] FDA K162575 — Z-LINKPC System ↗U.S. Food and Drug Administration · regulatory record
[50] FDA K162824 — Z-Span Plate System ↗U.S. Food and Drug Administration · regulatory record
[51] FDA K163104 — Terrace Anterior Cervical Plate System ↗U.S. Food and Drug Administration · regulatory record
[52] FDA K170821 — ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System ↗U.S. Food and Drug Administration · regulatory record
[53] FDA K170942 — The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems ↗U.S. Food and Drug Administration · regulatory record
[54] FDA K170953 — Tomcat Cervical Spinal System ↗U.S. Food and Drug Administration · regulatory record
[55] FDA K171456 — Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems ↗U.S. Food and Drug Administration · regulatory record
[56] FDA K171489 — Acapella Cervical Spacer System ↗U.S. Food and Drug Administration · regulatory record
[57] FDA K171519 — FLXfit ↗U.S. Food and Drug Administration · regulatory record
[58] FDA K171686 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System ↗U.S. Food and Drug Administration · regulatory record
[59] FDA K172816 — TiGer Shark System ↗U.S. Food and Drug Administration · regulatory record
[60] FDA K173215 — Choice Spine Laminoplasty Fixation System ↗U.S. Food and Drug Administration · regulatory record
[61] FDA K173306 — EZ Plate ↗U.S. Food and Drug Administration · regulatory record
[62] FDA K173752 — SI Screw System ↗U.S. Food and Drug Administration · regulatory record
[63] FDA K180076 — Ti 3Z Interbody System ↗U.S. Food and Drug Administration · regulatory record
[64] FDA K180519 — HARRIER-SA Lumbar Interbody System ↗U.S. Food and Drug Administration · regulatory record
[65] FDA K180537 — Zavation Buttress Plate System ↗U.S. Food and Drug Administration · regulatory record
[66] FDA K180556 — Corelink Foundation 3D Anterior Lumbar System ↗U.S. Food and Drug Administration · regulatory record
[67] FDA K180673 — Normandy VBR System ↗U.S. Food and Drug Administration · regulatory record
[68] FDA K180814 — CoreLink® M3 Stand-Alone Anterior Lumbar System ↗U.S. Food and Drug Administration · regulatory record
[69] FDA K181244 — Zavation Cervical Plate System ↗U.S. Food and Drug Administration · regulatory record
[70] FDA K181246 — Zavation IBF System ↗U.S. Food and Drug Administration · regulatory record
[71] FDA K182721 — Choice Spine Navigation System ↗U.S. Food and Drug Administration · regulatory record
[72] FDA K182731 — Corelink Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[73] FDA K183214 — Raven Lumbar Plate System ↗U.S. Food and Drug Administration · regulatory record
[74] FDA K183239 — CoreLink F3D Lateral System ↗U.S. Food and Drug Administration · regulatory record
[75] FDA K183397 — ChoiceSpine Stealth Cervical Spacer System ↗U.S. Food and Drug Administration · regulatory record
[76] FDA K183588 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System ↗U.S. Food and Drug Administration · regulatory record
[77] FDA K190016 — Lateral Plate System ↗U.S. Food and Drug Administration · regulatory record
[78] FDA K190227 — Boomerang Anterior Cervical Plate System ↗U.S. Food and Drug Administration · regulatory record
[79] FDA K190317 — Zavation Spinal System ↗U.S. Food and Drug Administration · regulatory record
[80] FDA K190361 — Zavation Spinal System ↗U.S. Food and Drug Administration · regulatory record
[81] FDA K191339 — Zavation eZspand Interbody System ↗U.S. Food and Drug Administration · regulatory record
[82] FDA K191354 — Ti3Z Cervical Interbody System ↗U.S. Food and Drug Administration · regulatory record
[83] FDA K191367 — Harrier-SA Lumbar Interbody System ↗U.S. Food and Drug Administration · regulatory record
[84] FDA K191423 — Normandy VBR System ↗U.S. Food and Drug Administration · regulatory record
[85] FDA K191621 — ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System ↗U.S. Food and Drug Administration · regulatory record
[86] FDA K200084 — Zavation IBF System ↗U.S. Food and Drug Administration · regulatory record
[87] FDA K200087 — F3D Cervical Stand-Alone Interbody Fusion System ↗U.S. Food and Drug Administration · regulatory record
[88] FDA K200863 — Tiger® Occipital-Cervical-Thoracic Spinal Fixation System ↗U.S. Food and Drug Administration · regulatory record
[89] FDA K201643 — ChoiceSpine Tiger Shark Cervical Spacer System ↗U.S. Food and Drug Administration · regulatory record
[90] FDA K201781 — Uni-FuZe-P Bone Putty ↗U.S. Food and Drug Administration · regulatory record
[91] FDA K202305 — Zavation IBF System ↗U.S. Food and Drug Administration · regulatory record
[92] FDA K202398 — Ti3Z Cervical Interbody System ↗U.S. Food and Drug Administration · regulatory record
[93] FDA K202624 — Z-Span Plate System ↗U.S. Food and Drug Administration · regulatory record
[94] FDA K202637 — F3D Corpectomy System ↗U.S. Food and Drug Administration · regulatory record
[95] FDA K203311 — ChoiceSpine Blackhawk Ti Cervical Spacer System ↗U.S. Food and Drug Administration · regulatory record
[96] FDA K203561 — ChoiceSpine Navigation System ↗U.S. Food and Drug Administration · regulatory record
[97] FDA K210539 — CoreLink Midline Fixation System ↗U.S. Food and Drug Administration · regulatory record
[98] FDA K211113 — Zavation Spinal System ↗U.S. Food and Drug Administration · regulatory record
[99] FDA K211306 — LABYRINTH ↗U.S. Food and Drug Administration · regulatory record
[100] FDA K211417 — F3D-C2 Cervical Stand-Alone System ↗U.S. Food and Drug Administration · regulatory record
[101] FDA K211449 — Triton Sacroiliac Joint Fixation System ↗U.S. Food and Drug Administration · regulatory record
[102] FDA K211993 — Z-LINKPC System ↗U.S. Food and Drug Administration · regulatory record
[103] FDA K212811 — Ti3Z Lumbar Interbody System ↗U.S. Food and Drug Administration · regulatory record
[104] FDA K212825 — CoreLink Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[105] FDA K214059 — CoreLink Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[106] FDA K220024 — ChoiceSpine Navigation System ↗U.S. Food and Drug Administration · regulatory record
[107] FDA K220581 — Zavation eZspand Interbody System ↗U.S. Food and Drug Administration · regulatory record
[108] FDA K220953 — ChoiceSpine TigerShark M, Modular Interbody System ↗U.S. Food and Drug Administration · regulatory record
[109] FDA K220973 — CoreLink Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[110] FDA K221049 — Zavation VariSync Plate System and VariSync Spacer System ↗U.S. Food and Drug Administration · regulatory record
[111] FDA K221726 — Uni-FuZe-C Bone Strip ↗U.S. Food and Drug Administration · regulatory record
[112] FDA K221776 — NextGen Pedicle Screw System ↗U.S. Food and Drug Administration · regulatory record
[113] FDA K222614 — Zavation Spinal System ↗U.S. Food and Drug Administration · regulatory record
[114] FDA K223708 — Entasis 3D Dual-Lead Sacroiliac Implant System ↗U.S. Food and Drug Administration · regulatory record
[115] FDA K223808 — Zavation Navigation Instrument System ↗U.S. Food and Drug Administration · regulatory record
[116] FDA K223869 — ChoiceSpine Blackhawk Ti Cervical Spacer System ↗U.S. Food and Drug Administration · regulatory record
[117] FDA K230329 — F3D Interbody System ↗U.S. Food and Drug Administration · regulatory record
[118] FDA K230731 — Zavation ALIF System ↗U.S. Food and Drug Administration · regulatory record
[119] FDA K230880 — CoreLink Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[120] FDA K231494 — CoreLink Robotic Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[121] FDA K231743 — F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System ↗U.S. Food and Drug Administration · regulatory record
[122] FDA K231811 — Zavation Connector System ↗U.S. Food and Drug Administration · regulatory record
[123] FDA K232116 — CoreLink Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[124] FDA K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System ↗U.S. Food and Drug Administration · regulatory record
[125] FDA K243908 — Tiger 2 System ↗U.S. Food and Drug Administration · regulatory record
[126] FDA K253943 — Tiger 2 System ↗U.S. Food and Drug Administration · regulatory record
[127] FDA De Novo database — research search ↗FDA / openFDA · regulatory record
[128] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[129] FDA PMA database — research search ↗FDA / openFDA · regulatory record
[130] FDA PMA database — research search ↗U.S. FDA / openFDA · regulatory database
[131] FDA recall Z-1700-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[132] FDA recall Z-1701-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[133] FDA recall Z-1702-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[134] FDA recall Z-1703-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[135] FDA recall Z-1704-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[136] FDA recall Z-1705-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[137] FDA recall Z-1706-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[138] FDA recall Z-1707-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[139] FDA recall Z-1708-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[140] FDA recall Z-1709-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[141] FDA recall Z-1710-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[142] FDA recall Z-1711-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[143] FDA recall Z-1712-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[144] FDA recall Z-1713-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[145] FDA recall Z-1714-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[146] FDA recall Z-1715-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[147] FDA recall Z-1716-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[148] FDA recall Z-1717-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[149] FDA recall Z-1718-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[150] FDA recall Z-1719-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[151] FDA recall Z-1720-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[152] FDA recall Z-1721-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[153] FDA recall Z-1722-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[154] FDA recall Z-1723-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[155] FDA recall Z-1724-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[156] FDA recall Z-1725-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[157] FDA recall Z-1726-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[158] FDA recall Z-1727-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[159] FDA recall Z-1728-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[160] FDA recall Z-1729-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[161] FDA recall Z-1730-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[162] FDA recall Z-1731-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[163] FDA recall Z-1732-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[164] FDA recall Z-1733-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[165] FDA recall Z-1734-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[166] FDA recall Z-1735-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[167] FDA recall Z-1736-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[168] FDA recall Z-1737-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[169] FDA recall Z-1738-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[170] FDA recall Z-1739-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[171] FDA recall Z-1740-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[172] FDA recall Z-1741-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[173] FDA recall Z-1742-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[174] FDA recall Z-1743-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[175] FDA recall Z-1744-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[176] FDA recall Z-1745-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[177] FDA recall Z-1746-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[178] FDA recall Z-1747-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[179] FDA recall Z-1748-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[180] FDA recall Z-1749-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[181] FDA recall Z-1750-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[182] FDA recall Z-1751-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[183] FDA recall Z-1752-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[184] FDA recall Z-1753-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[185] FDA recall Z-1754-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[186] FDA recall Z-1755-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[187] FDA recall Z-1756-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[188] FDA recall Z-1757-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[189] FDA recall Z-1758-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[190] FDA recall Z-1759-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[191] FDA recall Z-1760-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[192] FDA recall Z-1761-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[193] FDA recall Z-1762-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[194] FDA recall Z-1763-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[195] FDA recall Z-1764-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[196] FDA recall Z-1765-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[197] FDA recall Z-1766-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[198] FDA recall Z-1767-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[199] FDA recall Z-1768-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[200] FDA recall Z-1769-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[201] FDA recall Z-1770-2021 — Zavation ↗U.S. Food and Drug Administration · regulatory record
[202] FDA recall Z-0954-2023 — CoreLink LLC ↗U.S. Food and Drug Administration · regulatory record
[203] FDA medical-device recall database — research search ↗U.S. FDA / openFDA · regulatory database
[204] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[205] FDA medical-device recall database — research search ↗U.S. FDA / openFDA · regulatory database
[206] FDA event 87661 — vertebral augmentation recall ↗U.S. FDA / openFDA · regulatory database
[207] ChoiceSpine current portfolio and ownership ↗ChoiceSpine · company website
[208] ChoiceSpine Hawkeye VBR ↗ChoiceSpine · company website
[209] ChoiceSpine cervical catalog ↗ChoiceSpine · company website
[210] ChoiceSpine interbody catalog ↗ChoiceSpine · company website
[211] ChoiceSpine thoracolumbar catalog ↗ChoiceSpine · company website
[212] CoreLink product IFUs ↗CoreLink · manufacturer labeling
[213] CoreLink acquisition of Expanding Orthopedics ↗CoreLink · company announcement · Published 2018-06-05
[214] CoreLink posterior lumbar catalog — FLXfit15 ↗CoreLink · company website
[215] FDA De Novo applicant-name searches ↗U.S. FDA · regulatory database
[216] FDA event 91109 — FLXfit15 recall, terminated ↗U.S. FDA · regulatory database
[217] Pan Medical U.S. transaction ↗LongueVue Capital · owner announcement · Published 2018-09-18
[218] CoreLink acquisition ↗Gemspring Capital via PR Newswire · owner announcement · Published 2023-06-26
[219] Official website — current business and facilities ↗Zavation · company website
[220] Company history and operating model ↗Zavation · company website
[221] Current product and IFU index ↗Zavation · manufacturer labeling
[222] Current executive leadership ↗Zavation · company website
[223] Siber Ti current product page ↗Zavation · company website
[224] Tiger 2 current product page ↗Zavation · company website
[225] ZVplasty current kit portfolio ↗Zavation · company website
[226] Siber Ti IFU — navigation compatibility and limits ↗Zavation · manufacturer labeling
[227] ChoiceSpine acquisition and CEO appointment ↗Zavation · company announcement · Published 2026-02-26
[228] Varisync ALIF launch and first clinical use ↗Zavation · company announcement · Published 2024-09-10
[229] NanoPrime / Labyrinth cervical release ↗Zavation · company announcement · Published 2026-02-11