510(k) Report

Devices descending from K042025

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+3K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+3K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+3K100788Cocr RodsGlobus Medical, Inc.2010374—
+3K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+3K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+4K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243249TriALTIS™ Spine SystemMedos International SARL20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243693NEO Pedicle Screw System™Neo Medical SA20240—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—