510(k) Report

Devices descending from K063670

821 later devices reach Modifications to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201648Sterispine™ PSSafe Orthopaedics202011
+5K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—