510(k) Report

Devices descending from K041030

790 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K173508Everest Spinal SystemK2m20189—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+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—
+4K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+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—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+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—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+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
+4K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+4K121630Range Spinal SystemK2m, Inc.2012127—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+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—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—