510(k) Report

Devices descending from K000094

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+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—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140529Everest Spinal SystemK2m, LLC201431—
+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—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+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
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K121728Tiger Spine SystemCorelink, LLC201250—
+4K121172Reform Pedicle Screw SystemSpinal USA201233—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+4K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+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—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.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—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+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—
+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—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243249TriALTIS™ Spine SystemMedos International SARL20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243693NEO Pedicle Screw System™Neo Medical SA20240—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—