510(k) Report

Devices descending from P950002

1,681 later devices reach Bak Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K193106SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc.20200—
+4K200283Medussa-PL CageMedyssey USA, Inc.20200—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K200312Tryptik TiSpineart20202—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+4K192993Scarlet AL-TSpineart20201—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K193174Keos Lumbar IBFDKeos20190—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+4K190380nvcNvision Biomedical Technologies, Inc.20193—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K183259Idys™ TLIF TiVacClariance, Sas20191—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K181203Juliet TiSpineart20181—
+4K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+4K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—