510(k) Report

Devices descending from K050439

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+1K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+1K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+1K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+1K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K252322SIros-X SystemGenesys Spine20250—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+2K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+2K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K172115Navigated Instrument SystemOrthofix, Inc.20184—
+2K162921Navigated Instrument SystemOrthofix, Inc.20175—
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K142360Everest Spinal SystemK2m, Inc.201522—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K140529Everest Spinal SystemK2m, LLC201431—
+2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+2K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+2K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+3K202771CD Horizon Spinal SystemMedtronic202021—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K173508Everest Spinal SystemK2m20189—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K171321K2M Navigation InstrumentsK2m201711
+3K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+3K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161627PASS LP Spinal SystemMedicrea International SA20167—
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+3K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+3K151727Everest Spinal SystemK2m, Inc.201511—