510(k) Report

Devices descending from K023675

482 later devices reach Synthes Cervifix/ Axon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+1K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+1K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+1K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+1K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+1K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+1K100634Synthes Matrix SystemSynthes (Usa)2010316—
+1K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+1K070573Synapse SystemSynthes Spine Co.Lp2007378—
+1K052402Vertex Reconstruction SystemMedtronic Sofamor Danek2005180—
+1K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K152211PCT SystemCentinel Spine, Inc.20150—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+2K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+2K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+2K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+2K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K113149Synthes Uss ConnectorsSynthes Spine201293—
+2K113044Synthes MirsSynthes Spine2011933
+2K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+2K111358Synthes UssSynthes Spine2011151—
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+2K101084Caspian Spinal SystemK2m, Inc.201062—
+2K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+2K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+2K090343Sentinel Spinal SystemLife Spine200921—
+2K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+2K090549Synthes Synapse TransconnectorSynthes Spine20091—
+2K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+2K072434Synthes OC Fusion and Synapse SystemsSynthes Spine Co.Lp20082—
+2K071942Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek200724—
+2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+2K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2006151—
+2K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005175—
+3K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K121979Pass Oct Spinal SystemMedicrea International201314—
+3K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K120998Solstice Cross ConnectorLife Spine20121—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431