510(k) Report

Devices descending from K020709

1,146 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+4K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+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—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+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
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K113044Synthes MirsSynthes Spine2011933
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+4K100788Cocr RodsGlobus Medical, Inc.2010374—
+4K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+4K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K080928Xia Spinal System, Stainless Steel Uni-Planar ScrewsStryker Spine2008182—
+4K073151Mantis Spinal SystemStryker Corp.2007111—
+4K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+4K061813Mantis Spinal SystemStryker Spine20061352
+4K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243249TriALTIS™ Spine SystemMedos International SARL20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—