510(k) Report

Devices descending from K001532

997 later devices reach Dyna-Lok Classic Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K202505GetSet Surgical GoPLF! Posterior Lateral Fusion SystemGetset Surgical, SA20210—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K180324Patriot Spinal Fixation SystemValorus Spine20180—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+4K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171321K2M Navigation InstrumentsK2m201711
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+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—
+4K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+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—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+4K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—