510(k) Report

Devices descending from P950019

1,482 later devices reach Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K101085Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.201001
+2K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+2K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+2K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+2K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+2K083661Avs TL Peek SpacersStryker Corp.2009757—
+2K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+2K081196Spinal Usa VBR SystemSpinal USA200813—
+2K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+2K081636Peek-Optima Alif SpacerBiomet Spine2008542—
+2K082014Stryker Spine Avs PL Peek SpacersStryker Corp.2008837—
+2K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine2008854—
+2K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+2K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.20081,091—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+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—
+3K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+3K251431FIX-C PEEK ACIF SA 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—
+3K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+3K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+3K203003Pantheon IBFDPantheon Spinal20210—
+3K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—