510(k) Report

Devices descending from K141605

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+1K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+2K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+2K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+2K183381Navigation Enabled InstrumentsStryker20191—
+2K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+2K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+2K171321K2M Navigation InstrumentsK2m201711
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+2K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+2K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203816DeGen Navigated InstrumentationDegen Medical20211—
+3K210472SPINEART Navigation Instrument SystemSpineart20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+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—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213918DeGen Navigated InstrumentationDegen Medical20220—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+4K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+4K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+4K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—