510(k) Report

Devices descending from K041862

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+6K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+6K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+6K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.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—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+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—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+6K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—