510(k) Report

Devices descending from K041862

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K210637CD Horizon™ Spinal SystemMedtronic202134—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+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—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K173508Everest Spinal SystemK2m20189—
+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—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+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
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+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—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+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—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+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
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+4K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+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—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+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
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122592Instinct Java SystemZimmer Spine201301
+4K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K121728Tiger Spine SystemCorelink, LLC201250—
+4K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—