510(k) Report

Devices descending from K052054

786 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+1K101772TSRH (R) Spinal SystemMedtronic Sofamor Danek20100—
+1K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+1K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+1K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+1K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+1K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+2K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+2K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+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—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+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—
+2K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+2K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K100788Cocr RodsGlobus Medical, Inc.2010374—
+2K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+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—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+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—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+3K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K171321K2M Navigation InstrumentsK2m201711
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+3K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+3K161627PASS LP Spinal SystemMedicrea International SA20167—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+3K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+3K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—