510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+7K142271Zavation Z-Link LumbarZavation, LLC20149—
+7K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+7K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+7K141942Midline II TICentinel Spine, Inc.2014459—
+7K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+7K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+7K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K1421124WEB Spinal Implant Products4Web, Inc.201433—
+7K141005Z-Link CervicalZavation, LLC20144—
+7K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+7K140529Everest Spinal SystemK2m, LLC201431—
+7K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+7K133967Interbody Cage SystemAurora Spine2014227—
+7K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+7K130445Vault Alif SystemSpinal USA20139—
+7K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+7K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+7K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+7K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+7K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+7K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+7K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+7K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+7K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+7K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+7K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261430TruLift Expandable SystemLife Spine, Inc.20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K2530413d Cage CervicalFims Co., Ltd.20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K250560BEE HANGMedical GmbH20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+8K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—