510(k) Report

Devices descending from K043151

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+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—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+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—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K121728Tiger Spine SystemCorelink, LLC201250—
+4K121172Reform Pedicle Screw SystemSpinal USA201233—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+4K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+4K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—