510(k) Report

Devices descending from K040962

1,130 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K201648Sterispine™ PSSafe Orthopaedics202011
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+3K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+3K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173508Everest Spinal SystemK2m20189—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+3K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K142360Everest Spinal SystemK2m, Inc.201522—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K141398Pass LP Spinal SystemMedicrea International SA2015101
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—