510(k) Report

Devices descending from K091974

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221244CD Horizon™ Spinal SystemMedtronic202220—
+1K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+1K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+1K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+1K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+1K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+1K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+1K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+1K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+1K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+1K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+1K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+1K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+1K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+1K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+1K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+1K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+2K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+2K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+2K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+2K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+2K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+2K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+2K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+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—
+2K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+2K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+2K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+2K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+2K183381Navigation Enabled InstrumentsStryker20191—
+2K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+2K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+2K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K171321K2M Navigation InstrumentsK2m201711
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+2K161842Overwatch Spine SystemAmendia, Inc.201661
+2K161627PASS LP Spinal SystemMedicrea International SA20167—
+2K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+2K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K142360Everest Spinal SystemK2m, Inc.201522—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+2K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+2K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K140529Everest Spinal SystemK2m, LLC201431—
+2K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+2K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+2K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+2K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+2K122592Instinct Java SystemZimmer Spine201301
+2K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+2K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+2K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120564Calypso SystemHogan Lovells US LLP201216—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+3K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+3K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—