510(k) Report

Devices descending from K040583

1,161 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+4K143350Nile Alternative FixationK2m, Inc.201510—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K133103Aversion Pedicle Screw SystemK7, LLC20140—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K123138Pass LP Spinal SystemMedicrea International2013132—
+4K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+4K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+4K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121568Dali Spinal Fixation SystemAccel Spine20121—
+4K113666Xia 3 Spinal SystemStryker Spine2012251—
+4K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+4K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+4K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+4K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K113044Synthes MirsSynthes Spine2011933
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+4K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+4K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+4K111479Revere CrosstopGlobus Medical, Inc.2011232—
+4K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+4K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+4K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+4K101144Modification to:Radius Spinal SystemStryker Spine201090—