510(k) Report

Devices descending from K101074

225 later devices reach Modification to: CD Horizon (R) Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140449CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201459—
+1K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K151216Everest Spinal SystemK2m, Inc.201511—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K142360Everest Spinal SystemK2m, Inc.201522—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K141398Pass LP Spinal SystemMedicrea International SA2015101
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K140529Everest Spinal SystemK2m, LLC201431—
+2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+3K173508Everest Spinal SystemK2m20189—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K160640PASS XS Spinal SystemMedicrea International SA20160—
+3K161627PASS LP Spinal SystemMedicrea International SA20167—
+3K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+3K153413PASS LP Spinal SystemMedicrea International SA20160—
+3K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+3K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K231515MySpine Cervical GuidesMedacta International S.A.20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—