510(k) Report

Devices descending from K992739

912 later devices reach Click'x through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K203023Pisces Spinal SystemOrtho Development Corporation20210—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173508Everest Spinal SystemK2m20189—
+3K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150185Mont Blanc Spinal SystemSpineway20154—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—