510(k) Report

Devices descending from K123752

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K162262Tritanium® PL CageStryker2016132—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160955Tritanium® PL CageStryker2016178—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200312Tryptik TiSpineart20202—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K183243Velofix TLIF CageU&I Corporation20190—