510(k) Report

Devices descending from K032033

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+3K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K152174Sniper Spine SystemSpine Wave, Inc.20158—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+3K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133103Aversion Pedicle Screw SystemK7, LLC20140—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K121728Tiger Spine SystemCorelink, LLC201250—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K121172Reform Pedicle Screw SystemSpinal USA201233—
+3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+3K120696Tiger Spine SystemCorelink, LLC201241—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K113044Synthes MirsSynthes Spine2011933
+3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+3K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—