510(k) Report

Devices descending from K001864

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100634Synthes Matrix SystemSynthes (Usa)2010316—
+1K060683Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200632—
+1K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001660—
+1K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000671—
+2K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+2K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+2K121979Pass Oct Spinal SystemMedicrea International201314—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K113149Synthes Uss ConnectorsSynthes Spine201293—
+2K113044Synthes MirsSynthes Spine2011933
+2K111358Synthes UssSynthes Spine2011151—
+2K101084Caspian Spinal SystemK2m, Inc.201062—
+2K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+2K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology201024—
+2K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008242—
+2K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200731—
+2K070638Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC200759—
+2K062934SierraSeaspine, Inc.200621—
+2K052201Solanas Posterior Stabilization SystemAlphatec Spine, Inc.2005363
+2K050979S4 Spinal SystemAesculap, Inc.200567—
+2K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+2K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004301—
+2K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004657—
+2K030197Blackstone Posterior Cervical SystemBlackstone Medical, Inc.20031931
+2K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003658—
+2K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002659—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+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—
+3K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+3K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K150918PASS OCT Spinal SystemMedicrea International SA201513—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+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—
+3K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+3K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133214Blackbird Spinal SystemChoicespine, LP20143—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133698Synapse SystemSynthes USA Products, LLC20146—
+3K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K132332Mountaineer Oct Spinal SystemMedos International SARL20134—
+3K131119Solanas Posterior Stabilization SystemAlphatec Spine, Inc.201301
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+3K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+3K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+3K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+3K112757Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc.2012181
+3K113654CaspianK2m, Inc.201244—
+3K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+3K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+3K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+3K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+3K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011156—