510(k) Report

Devices descending from K032265

1,192 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K122592Instinct Java SystemZimmer Spine201301
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K121728Tiger Spine SystemCorelink, LLC201250—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121172Reform Pedicle Screw SystemSpinal USA201233—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+3K120696Tiger Spine SystemCorelink, LLC201241—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K113044Synthes MirsSynthes Spine2011933
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+3K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+3K101772TSRH (R) Spinal SystemMedtronic Sofamor Danek20100—
+3K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+3K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+3K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+3K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+3K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+3K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+3K061813Mantis Spinal SystemStryker Spine20061352
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+3K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+3K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+3K050981CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005786—
+4K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+4K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—