510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+6K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+6K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K150481Cascadia Interbody SystemK2m, Inc.20154593
+6K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+6K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+6K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+6K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K142744Mecta-C TiPEEKMedacta International201512—
+6K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K140348Interbody CageEisertech, LLC2015235—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K143616AccuLIF TL and PL CageStryker Corporation20154694
+6K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K142030STGC-LordoticCardinal Spine, LLC201558—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K141135Juliet LLSpineart2014146—
+6K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+6K141896Coroent SystemNu Vasive, Incorporated2014480—
+6K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+6K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+6K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K142381Xia 3 Spinal SystemStryker Corp.201483—
+6K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+6K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+6K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+6K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+6K133717Longbow Spacer SystemLife Spine20149—
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140280ForticoreNanovis, LLC20149—
+6K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+6K141044M.U.S.T. ExtensionMedacta International201416—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+6K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+6K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K140303Alamo TAlliance Partners, LLC20140—
+6K132738Cogent Med-LifCogent Spine, LLC201413—
+6K132596Proposed OptimusCustom Spine, Inc.201451
+6K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K133614Aleutian Ibf SystemK2m, Inc.2014527—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+6K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+6K133967Interbody Cage SystemAurora Spine2014227—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K132878M.U.S.T. ExtensionMedacta International201328—
+6K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+6K133207Staxx (R) SystemSpine Wave, Inc.20131—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K131178Idys Lif CagesClariance201311—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K131343Reform Pedicle Screw SystemSpinal USA201331—