510(k) Report

Devices descending from K043488

1,128 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173126Arisstos™ Spinal SystemIngenium Spine20171—
+1K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+1K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+1K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+1K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+1K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+1K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+1K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+1K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+1K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+1K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+1K050981CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005786—
+2K241258Ingenix Spinal SystemIngenium Spine20240—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+2K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+2K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+2K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+2K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+2K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+2K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+2K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K101074Modification to: CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2010225—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K100788Cocr RodsGlobus Medical, Inc.2010374—
+2K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+2K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+2K090390CD Horizon Spinal SystemMedtronic Sofamor Danek2009663—
+2K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+2K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+2K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+2K072605Malibu Spinal SystemSeaspine, Inc.200767—
+2K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+2K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+2K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+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—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—