510(k) Report

Devices descending from K011508

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K171321K2M Navigation InstrumentsK2m201711
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+5K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+5K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+5K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+5K142381Xia 3 Spinal SystemStryker Corp.201483—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+5K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+5K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+5K121630Range Spinal SystemK2m, Inc.2012127—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+5K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—