510(k) Report

Devices descending from K031655

1,220 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+3K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161627PASS LP Spinal SystemMedicrea International SA20167—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K152324YAHUA Spinal SystemBeijing Weigao Yahua Artificial Joint Development Co., Ltd.20160—
+3K143013Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K142360Everest Spinal SystemK2m, Inc.201522—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K140053Kangli Pedicle Screw Spinal SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20143—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+3K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+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—
+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—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123552Instinct Java SystemZimmer Spine201301
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+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—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K113270Instinct Java SystemZimmer Spine201121
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+3K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+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
+3K101074Modification to: CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2010225—
+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—
+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—