510(k) Report

Devices descending from K041203

657 later devices reach Summit Oct Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K132332Mountaineer Oct Spinal SystemMedos International SARL20134—
+1K121979Pass Oct Spinal SystemMedicrea International201314—
+1K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+1K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc.2010184—
+1K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008242—
+1K072568Modification to Oasys SystemStryker Spine200744—
+1K062934SierraSeaspine, Inc.200621—
+1K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+1K050979S4 Spinal SystemAesculap, Inc.200567—
+1K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+1K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004301—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+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—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+2K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K150918PASS OCT Spinal SystemMedicrea International SA201513—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+2K133214Blackbird Spinal SystemChoicespine, LP20143—
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+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
+2K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+2K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+2K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+2K111719Oasys Spinal SystemStryker Spine201239—
+2K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+2K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+2K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011156—
+2K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+2K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+2K103232Caspian Spinal SystemK2m, Inc.201146—
+2K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K101183Modification to: Oasys SystemStryker Spine20100—
+2K101084Caspian Spinal SystemK2m, Inc.201062—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010—
+2K093670Modification to: Oasys SystemStryker Spine201041Class I
+2K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+2K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+2K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+2K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+2K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+2K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+2K083073Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20098—
+2K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+2K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+2K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+2K072729SierraSeaspine, Inc.20085—
+2K080526Sierra SystemSeaspine, Inc.20089—
+2K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+2K080143Modification to Stryker Spine Oasys SystemStryker Spine200843—
+2K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc.2008129—
+2K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+2K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+2K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+2K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+2K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+2K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+2K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—