510(k) Report

Devices descending from K963655

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181397DualXInnovasive, Inc.201815—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K173508Everest Spinal SystemK2m20189—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K171321K2M Navigation InstrumentsK2m201711
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+4K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+4K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K122592Instinct Java SystemZimmer Spine201301
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+4K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—