510(k) Report

Devices descending from P950002

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+2K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+2K111965Vusion (R) OSOrtho Development20110—
+2K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+2K111553Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc.201114—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+2K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+2K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+2K111569Plateau Spacer SystemLife Spine2011181—
+2K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+2K110843Aleutian Spacer SystemK2m, Inc.2011589—
+2K110927MectalifMedacta International2011301
+2K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+2K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+2K110067LP CageMedyssey Co, Ltd.201115—
+2K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+2K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K103169AleuttianK2m, Inc.2011572—
+2K103488Concorde Bullet Cage SystemJohnson and Johnson201129—
+2K102738Lanx Fusion SystemLanx, LLC20113281
+2K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+2K101923Concorde Curve SystemDepuy Spine2010609—
+2K093093Small Plateau Spacer SystemLife Spine2010393—
+2K102090Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSpine Smith Partners L.P.20104731
+2K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+2K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+2K100889Endoskeleton TCTitan Spine, LLC2010455—
+2K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+2K101302Aleutian Ibf SystemK2m, Inc.2010595—
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+2K101085Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.201001
+2K092815S-Lif Intervertebral Body Fusion DeviceSpinefrontier, Inc.2010156
+2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+2K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+2K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies2010322
+2K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+2K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+2K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+2K091638Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031Spinefrontier, Inc.200915—
+2K081888Dynamik Intervertebral Body Fusion DeviceSpineart2009282—
+2K083167Phenix Cervical Interbody DeviceSpinal Devices, LLC200914—
+2K081196Spinal Usa VBR SystemSpinal USA200813—
+2K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+2K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+2K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+2K081636Peek-Optima Alif SpacerBiomet Spine2008542—
+2K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine2008854—
+2K080673Interfuse Intervertebral Body Fusion DeviceVertebral Technologies, Inc.2008103—
+2K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+2K080588Scient'x Tribeca VBRScient'X USA, Inc.2008250—
+2K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+2K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+2K073502Vertebron VBR SystemVertebron, Inc.200812—
+2K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102—
+2K072981Synthes Zero-PSynthes Spine Co.Lp20085462
+3K261408SABER-XA SystemElevation Spine20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K243973FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation20250—
+3K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—