510(k) Report

Devices descending from K041777

1,130 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043488Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek20051,128—
+1K042886CD Horizon Spinal SystemMedtronic Sofamor Danek2004779—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+2K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+2K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+2K050981CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005786—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+3K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+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—
+3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+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—
+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
+3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+3K090390CD Horizon Spinal SystemMedtronic Sofamor Danek2009663—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+3K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+3K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+3K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+3K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+3K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—