510(k) Report

Devices descending from K110270

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181048Neo Cage System TMNeo Medical SA20191—
+7K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+7K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+7K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+7K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+7K172419Velofix™ TLIF CageU&I Corporation20172—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K162262Tritanium® PL CageStryker2016132—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+7K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+7K160955Tritanium® PL CageStryker2016178—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+7K160125Cascadia Interbody SystemK2m2016315—
+7K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+8K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+8K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+8K223326Axiom PSR SystemRestor3D202301
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+8K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+8K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+8K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+8K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+8K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+8K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+8K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+8K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+8K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+8K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+8K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+8K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+8K182477Cervical SpacerAdditive Implants, LLC201915—
+8K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+8K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+8K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+8K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+8K181829Velofix TLIF CageU&I Corporation20181—
+8K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+8K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+8K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+8K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+8K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K171312FortiCore®Nanovis, LLC20183—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+8K170235Lucent®Spinal Elements, Inc.2017107—
+8K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+8K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+8K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+8K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+8K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711