510(k) Report

Devices descending from K020709

1,146 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+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—
+3K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+3K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+3K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+3K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+3K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+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—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+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—
+3K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K122592Instinct Java SystemZimmer Spine201301
+3K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K101772TSRH (R) Spinal SystemMedtronic Sofamor Danek20100—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+3K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+3K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+3K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+3K083393Xia 3 Spinal SystemStryker Spine20092921
+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—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+3K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+3K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20067341