510(k) Report

Devices descending from K091974

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K252322SIros-X SystemGenesys Spine20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+3K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203816DeGen Navigated InstrumentationDegen Medical20211—
+3K210472SPINEART Navigation Instrument SystemSpineart20215—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K201648Sterispine™ PSSafe Orthopaedics202011
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173508Everest Spinal SystemK2m20189—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—