510(k) Report

Devices descending from K043151

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+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—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+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—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—