510(k) Report

Devices descending from K143616

469 later devices reach AccuLIF TL and PL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+1K152651AccuLIF TL and PL CageStryker Corporation201530—
+1K152304Tritanium PL CageStryker20154481
+2K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+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—
+2K181397DualXInnovasive, Inc.201815—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+2K162262Tritanium® PL CageStryker2016132—
+2K160955Tritanium® PL CageStryker2016178—
+2K160715AccuLIF TL and PL CageStryker Corporation20160—
+2K160125Cascadia Interbody SystemK2m2016315—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+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—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K211740DualXAmplify Surgical, Inc.20211—
+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—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+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—
+3K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+3K200312Tryptik TiSpineart20202—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K181014Tritanium PL CageStryker Spine2018137—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+3K171312FortiCore®Nanovis, LLC20183—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K261049Scala® TLSpineart SA20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—