510(k) Report

Devices descending from K102555

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+1K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+1K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+1K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+1K122877Range Spinal System, Small StatureK2m, Inc.201334—
+1K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+1K121630Range Spinal SystemK2m, Inc.2012127—
+1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+1K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+2K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+2K252322SIros-X SystemGenesys Spine20250—
+2K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+2K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+2K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+2K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+2K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+2K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+2K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+2K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+2K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+2K183381Navigation Enabled InstrumentsStryker20191—
+2K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K172115Navigated Instrument SystemOrthofix, Inc.20184—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K171321K2M Navigation InstrumentsK2m201711
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+2K162921Navigated Instrument SystemOrthofix, Inc.20175—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+2K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+2K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+2K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+2K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K122592Instinct Java SystemZimmer Spine201301
+2K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+2K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120564Calypso SystemHogan Lovells US LLP201216—
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—