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
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+4K210306GII Spinal Fixation SystemColigne AG20210—
+4K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+4K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+4K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171321K2M Navigation InstrumentsK2m201711
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—