510(k) Report

Devices descending from P970015

1,426 later devices reach Inter Fix Threaded Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K230026SqualeImplanet, S.A.20230—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K230583Tryptik TiSpineart SA20231—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K201793EDEN Peek CageJmt Co., Ltd.20210—
+5K211413BEE PLIF CageNGMedical GmbH20211—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K202380Born PT-LIF Cage HASpineworxx AG20210—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K200429BEE CagesNGMedical GmbH202111—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K192897icotec Cervical CageIcotec AG20201—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—