510(k) Report

Devices descending from K102807

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+1K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+1K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+1K122877Range Spinal System, Small StatureK2m, Inc.201334—
+1K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+1K121630Range Spinal SystemK2m, Inc.2012127—
+1K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+1K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+1K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+2K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+2K190376PASS LP Spinal SystemMedicrea International SA201915
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+2K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—