510(k) Report

Devices descending from K001255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+1K061813Mantis Spinal SystemStryker Spine20061352
+1K043343Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004595—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K073151Mantis Spinal SystemStryker Corp.2007111—
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+2K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+3K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+3K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K162367Erisma® LP MISClariance, Sas20162—
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K121630Range Spinal SystemK2m, Inc.2012127—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+4K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+4K103292Trio Trauma Spinal SystemStryker Corporation201185—
+4K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—