510(k) Report

Devices descending from K050981

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+6K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+6K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+6K142499Reline SystemNu Vasive, Incorporated201478—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—