510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+4K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+4K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+4K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+4K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+4K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+4K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+4K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+4K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+4K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+4K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+4K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+4K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+5K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+5K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+5K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—