510(k) Report

Devices descending from K143163

636 later devices reach AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+1K201585Monterey AL Interbody SystemStryker Corporation202044
+1K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+1K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+1K153665Prow Fusion-LNlt Spine, Ltd.20160—
+1K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+1K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+1K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+1K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+1K152304Tritanium PL CageStryker20154481
+1K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+1K143616AccuLIF TL and PL CageStryker Corporation20154694
+2K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+2K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+2K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+2K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+2K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K162262Tritanium® PL CageStryker2016132—
+2K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K160955Tritanium® PL CageStryker2016178—
+2K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K152651AccuLIF TL and PL CageStryker Corporation201530—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+3K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+3K200312Tryptik TiSpineart20202—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—