510(k) Report

Devices descending from K060615

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213918DeGen Navigated InstrumentationDegen Medical20220—
+7K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+7K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+7K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+7K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+7K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+7K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+7K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K180324Patriot Spinal Fixation SystemValorus Spine20180—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+7K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+7K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+7K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—