510(k) Report

Devices descending from K032033

1,106 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+1K100605Mis SystemSpine Wave, Inc.201033—
+1K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+1K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+1K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20067341
+1K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+1K041801Expedium Mis Spine SystemDepuy Spine, Inc.2004533—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+2K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+2K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K151813Sniper Spine SystemSpine Wave, Inc.20159—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+2K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K100757Tilock Pedicle Screw SystemGenesys Spine201091
+2K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+2K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+2K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+2K080928Xia Spinal System, Stainless Steel Uni-Planar ScrewsStryker Spine2008182—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K073151Mantis Spinal SystemStryker Corp.2007111—
+2K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+2K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+2K071860Modification to: Viper Spine SystemDepuy Spine, Inc.2007423—
+2K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+2K061813Mantis Spinal SystemStryker Spine20061352
+2K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+2K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+2K061520Viper Spine SystemDepuy Spine, Inc.2006517—
+2K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+2K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+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—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+3K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—