510(k) Report

Devices descending from K001066

768 later devices reach CD Horizon Eclipse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K173508Everest Spinal SystemK2m20189—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171321K2M Navigation InstrumentsK2m201711
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K170647Connector SystemOrthofix, Inc.201718—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K161267Response BandLoc Spinal FixationOrthoPediatrics Corp.201611
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+5K143350Nile Alternative FixationK2m, Inc.201510—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K132395LigapassMedicrea International201323—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K132287Jazz SystemHogan Lovells US LLP201315—
+5K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K121541Jazz SystemImplanet, S.A.201227—
+5K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+5K121250OP Spine SystemOrthoPediatrics Corp.201218—
+5K113044Synthes MirsSynthes Spine2011933
+5K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+5K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+5K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+5K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—