510(k) Report

Devices descending from K113529

316 later devices reach CD Horizon Voyager 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—
+1K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+1K121630Range Spinal SystemK2m, Inc.2012127—
+1K120838Synthes Matrix SystemSynthes Spine201216—
+1K120928Synthes Matrix SystemSynthes Spine20120—
+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—
+2K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+2K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+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—
+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—
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+2K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K171321K2M Navigation InstrumentsK2m201711
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K153404Zavation Spinal SystemZavation, LLC20161—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+2K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+2K141850Flospine Pedicle Screw SystemFlospine20140—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K253545Vulcan Spinal SystemK2m, 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
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+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—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+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—
+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—
+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—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—