510(k) Report

Devices descending from K132505

645 later devices reach Acculif TL and PL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172756Varian cageMedyssey USA, Inc.20171—
+1K141217Acculif TL and PL CageStryker Corporation20146423
+2K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+2K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K162262Tritanium® PL CageStryker2016132—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160955Tritanium® PL CageStryker2016178—
+4K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K200312Tryptik TiSpineart20202—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—