510(k) Report

Devices descending from K010681

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+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—
+3K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+3K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+3K101183Modification to: Oasys SystemStryker Spine20100—
+3K101084Caspian Spinal SystemK2m, Inc.201062—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+3K093670Modification to: Oasys SystemStryker Spine201041Class I
+3K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+3K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+3K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138—
+3K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+3K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+3K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+3K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc.2008124—
+3K080143Modification to Stryker Spine Oasys SystemStryker Spine200843—
+3K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+3K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+3K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+3K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+3K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+3K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+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—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230614Cortium™Ulrich Medical USA20230—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+4K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+4K173508Everest Spinal SystemK2m20189—
+4K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—