510(k) Report

Devices descending from K001864

733 later devices reach Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K103232Caspian Spinal SystemK2m, Inc.201146—
+3K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc.2010184—
+3K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010—
+3K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+3K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+3K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+3K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+3K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+3K083073Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20098—
+3K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+3K080790Modification to Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20089—
+3K072729SierraSeaspine, Inc.20085—
+3K080526Sierra SystemSeaspine, Inc.20089—
+3K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc.2008124—
+3K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.20080—
+3K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+3K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.20080—
+3K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc.2008129—
+3K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+3K072568Modification to Oasys SystemStryker Spine200744—
+3K071380Modification to Solanas Posterior Stabilization SystemAlphatec Spine, Inc.2007183
+3K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+3K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+3K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+3K042100Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorBlackstone Medical, Inc.2004139—
+3K033980Blackstone Ascent Poct System Hooks (System Modification)Blackstone Medical, Inc.2004134—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231654NorthStar OCT SystemSeaspine, Inc.20230—
+4K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K173047The Solstice OCT SystemLife Spine, Inc.20180—
+4K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K161149PASS OCT Spinal SystemMedicrea International SA20160—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+4K160756PASS OCT Spinal SystemMedicrea International SA20160—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—