510(k) Report

Devices descending from K122862

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+1K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+1K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+2K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+2K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+2K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+2K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+2K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+2K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K202771CD Horizon Spinal SystemMedtronic202021—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+3K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K171321K2M Navigation InstrumentsK2m201711
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+4K210306GII Spinal Fixation SystemColigne AG20210—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203816DeGen Navigated InstrumentationDegen Medical20211—
+4K210472SPINEART Navigation Instrument SystemSpineart20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—