510(k) Report

Devices descending from K052747

528 later devices reach Modification to:CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+1K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+1K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+1K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+1K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+1K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+2K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+2K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+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—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171321K2M Navigation InstrumentsK2m201711
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—