510(k) Report

Devices descending from K994187

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230614Cortium™Ulrich Medical USA20230—
+1K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+1K171834G Surgical OCT Spinal SystemG Surgical, LLC20170—
+1K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+1K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000671—
+2K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+2K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+2K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K150918PASS OCT Spinal SystemMedicrea International SA201513—
+2K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+2K121979Pass Oct Spinal SystemMedicrea International201314—
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K101084Caspian Spinal SystemK2m, Inc.201062—
+2K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology201024—
+2K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008242—
+2K070638Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC200759—
+2K062934SierraSeaspine, Inc.200621—
+2K052201Solanas Posterior Stabilization SystemAlphatec Spine, Inc.2005363
+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—
+2K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001660—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+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—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+3K161149PASS OCT Spinal SystemMedicrea International SA20160—
+3K160756PASS OCT Spinal SystemMedicrea International SA20160—
+3K153169PASS OCT Patient Specific RodsMedicrea International20164—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+3K133214Blackbird Spinal SystemChoicespine, LP20143—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133698Synapse SystemSynthes USA Products, LLC20146—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K132332Mountaineer Oct Spinal SystemMedos International SARL20134—
+3K131119Solanas Posterior Stabilization SystemAlphatec Spine, Inc.201301
+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—
+3K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+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
+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—
+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—
+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—
+3K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+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
+3K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+3K050979S4 Spinal SystemAesculap, Inc.200567—
+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—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K231654NorthStar OCT SystemSeaspine, Inc.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—