510(k) Report

Devices descending from K032265

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+4K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+4K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K120899Range Spinal System, Unit RodK2m, Inc.201235—
+4K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+4K120571Synthes Uss ConnectorSynthes Spine201274—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+4K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+4K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+4K101070Expedium Spine SystemMedos International SARL20102601
+4K101074Modification to: CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2010225—
+4K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K100788Cocr RodsGlobus Medical, Inc.2010374—
+4K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+4K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+4K092605Xia 4.5 Spinal SystemStryker Spine200998—
+4K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+4K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+4K092631Mantis Redux Spinal SystemStryker Spine2009110—
+4K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K090390CD Horizon Spinal SystemMedtronic Sofamor Danek2009663—
+4K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+4K072605Malibu Spinal SystemSeaspine, Inc.200767—
+4K073151Mantis Spinal SystemStryker Corp.2007111—
+4K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+4K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+4K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+4K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+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—
+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—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+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—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+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—
+5K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243249TriALTIS™ Spine SystemMedos International SARL20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243693NEO Pedicle Screw System™Neo Medical SA20240—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233684TriALTIS™ Spine SystemMedos International SARL20234—