510(k) Report

Devices descending from K121683

682 later devices reach Acculif TL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+6K162262Tritanium® PL CageStryker2016132—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160955Tritanium® PL CageStryker2016178—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+7K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200312Tryptik TiSpineart20202—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—