510(k) Report

Devices descending from K082572

659 later devices reach Uss Iliosacral, Uss Polyaxial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+2K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+2K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+2K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+3K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+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—
+3K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K172206NAJA™ Ligament Correction SystemCousin Biotech Sas20182—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+3K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+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—
+3K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+3K170647Connector SystemOrthofix, Inc.201718—
+3K162764Jazz Frame SystemImplanet, S.A.20176—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K161267Response BandLoc Spinal FixationOrthoPediatrics Corp.201611
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—