510(k) Report

Devices descending from K060615

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+5K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+5K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+5K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+5K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+5K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+5K122592Instinct Java SystemZimmer Spine201301
+5K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+5K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+5K121630Range Spinal SystemK2m, Inc.2012127—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+5K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—