510(k) Report

Devices descending from K001532

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173508Everest Spinal SystemK2m20189—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K171838TiLock2 Spinal SystemGenesys Spine20174—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141398Pass LP Spinal SystemMedicrea International SA2015101
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K142381Xia 3 Spinal SystemStryker Corp.201483—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+5K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+5K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+5K111479Revere CrosstopGlobus Medical, Inc.2011232—
+5K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+5K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—