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
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+4K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+4K141896Coroent SystemNu Vasive, Incorporated2014480—
+4K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+4K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+4K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K140280ForticoreNanovis, LLC20149—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+4K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+4K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated2014483—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K130445Vault Alif SystemSpinal USA20139—
+4K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+4K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K092574Esl Spinal SystemEbi, L.P.2010181—
+4K092336C-Thru Spinal SystemEbi, L.P.2009492—
+4K091381Ibex Spinal SystemEbi, L.P.2009181—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+5K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—