510(k) Report

Devices descending from K042962

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K132878M.U.S.T. ExtensionMedacta International201328—
+1K121764CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201245—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+1K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+1K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+1K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+1K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+1K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+1K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+2K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K151977icotec Pedicle SystemIcotec AG201630—
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA201443—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K123552Instinct Java SystemZimmer Spine201301
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+2K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+2K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+2K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+2K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+2K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.20181—
+3K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated201524—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+3K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+3K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+3K142114Xia® Growth Rod Conversion SetStryker Corporation201413—
+3K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.201427—