510(k) Report

Devices descending from K022190

659 later devices reach Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008242—
+1K062934SierraSeaspine, Inc.200621—
+1K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004301—
+1K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004657—
+1K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003658—
+2K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+2K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+2K193129Yukon OCT Spinal SystemK2m, Inc.202001
+2K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K132332Mountaineer Oct Spinal SystemMedos International SARL20134—
+2K121979Pass Oct Spinal SystemMedicrea International201314—
+2K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+2K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+2K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011156—
+2K103232Caspian Spinal SystemK2m, Inc.201146—
+2K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc.2010184—
+2K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010—
+2K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+2K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+2K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+2K083073Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20098—
+2K072729SierraSeaspine, Inc.20085—
+2K080526Sierra SystemSeaspine, Inc.20089—
+2K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+2K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc.2008129—
+2K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+2K072568Modification to Oasys SystemStryker Spine200744—
+2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+2K050979S4 Spinal SystemAesculap, Inc.200567—
+2K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K173047The Solstice OCT SystemLife Spine, Inc.20180—
+3K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+3K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+3K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K150918PASS OCT Spinal SystemMedicrea International SA201513—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+3K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133214Blackbird Spinal SystemChoicespine, LP20143—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+3K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+3K120998Solstice Cross ConnectorLife Spine20121—
+3K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+3K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+3K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K113346Neon SystemUlrich GmbH & Co. KG20121—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+3K111719Oasys Spinal SystemStryker Spine201239—
+3K113654CaspianK2m, Inc.201244—
+3K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+3K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+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
+3K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—