510(k) Report

Devices descending from K132639

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+1K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+1K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+1K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+1K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+1K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+1K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+2K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+2K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+2K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+2K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+2K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+2K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+2K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+2K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+2K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+2K183381Navigation Enabled InstrumentsStryker20191—
+2K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+2K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K171321K2M Navigation InstrumentsK2m201711
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+3K253249TriALTIS™ Spine SystemMedos International SARL20251—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+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—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+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—
+3K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+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—
+3K202771CD Horizon Spinal SystemMedtronic202021—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+3K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—