510(k) Report

Devices descending from K050809

870 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181397DualXInnovasive, Inc.201815—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K140734Nextgen Altius Oct SystemEbi, LLC20140—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+5K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+5K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+5K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+5K113346Neon SystemUlrich GmbH & Co. KG20121—
+5K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—