510(k) Report

Devices descending from K981676

1,218 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated201524—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K141398Pass LP Spinal SystemMedicrea International SA2015101
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+3K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+3K142114Xia® Growth Rod Conversion SetStryker Corporation201413—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.201427—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K122592Instinct Java SystemZimmer Spine201301
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+3K110679Del Mar Monoaxial Pedicle Screw SystemPhygen, LLC20110—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+3K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+3K101772TSRH (R) Spinal SystemMedtronic Sofamor Danek20100—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K100788Cocr RodsGlobus Medical, Inc.2010374—
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+3K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+3K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+3K092605Xia 4.5 Spinal SystemStryker Spine200998—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+3K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+3K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+3K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+3K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+3K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—