510(k) Report

Devices descending from K090390

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.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—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+5K180324Patriot Spinal Fixation SystemValorus Spine20180—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+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
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+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—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—