510(k) Report

Devices descending from K142838

192 later devices reach Synapse Occipital-Cervical-Thoracic (OCT) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+1K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+1K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+1K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+1K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+1K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+1K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+1K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+1K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+1K181949SYMPHONY™ OCT SystemMedos International SARL201810—
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+1K171834G Surgical OCT Spinal SystemG Surgical, LLC20170—
+1K172594Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.201712—
+1K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+1K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+1K170804The Solstice OCT SystemLife Spine, Inc.20173—
+1K162575Z-LINKPC SystemZavation, LLC20173—
+1K162639Proficient™ Posterior Cervical Spine SystemSpine Wave, Inc.201713—
+1K161637Poseidon OCT Spinal Fixation SystemMedyssey USA, Inc.20170—
+1K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+1K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+1K160697Gibralt® Spine System and Gibralt® Occipital Spine SystemExactech, Inc.20165—
+1K152211PCT SystemCentinel Spine, Inc.20150—
+1K151938S4 Cervical Spinal and Occiput SystemsAesculap Implant Systems, LLC20152—
+1K150474NuVasive VuePoint II OCT SystemNu Vasive, Incorporated201526—
+1K150650neon3Ulrich GmbH & Co. KG2015101
+1K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc.201541—
+1K151224Lineum OCT Spine SystemBiomet Spine2015231
+1K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+1K150822Centurion POCT SystemOrthofix, Inc.201523—
+1K150539OASYS SystemStryker Corporation201534—
+2K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+2K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+2K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+2K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+2K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+2K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+2K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+2K233366SYMPHONY OCT SystemMedos International SARL20230—
+2K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+2K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+2K230614Cortium™Ulrich Medical USA20230—
+2K220658COSY Cervicothoracic Occipital Rod-Screw SystemSignus Medizintechnik GmbH20220—
+2K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+2K213871Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC20220—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K220025ARx® Spinal SystemLife Spine, Inc.20220—
+2K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+2K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+2K200896Solstice CCILife Spine, Inc.20200—
+2K192013VERTICALE® Cervical SystemSilony Medical GmbH20202—
+2K193129Yukon OCT Spinal SystemK2m, Inc.202001
+2K192014SYPMHONY™ OCT SystemMedos International SARL20203—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K192354Innovasis Gibralt Spine SystemInnovasis, Inc.20190—
+2K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+2K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Medos International SARL20199—
+2K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K181440Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.20184—
+2K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+2K173047The Solstice OCT SystemLife Spine, Inc.20180—
+2K180025Centurion POCT SystemOrthofix, Inc.20186—
+2K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+2K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K170647Connector SystemOrthofix, Inc.201718—
+2K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+2K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+2K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+2K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+2K153336VuePoint OCT SystemNu Vasive, Incorporated20162—
+2K151755OASYS (r) SystemStryker Corporation201533—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—