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
+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
+3K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+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—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+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—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+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—
+4K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+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—
+4K200896Solstice CCILife Spine, Inc.20200—
+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—
+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—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+4K161149PASS OCT Spinal SystemMedicrea International SA20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160756PASS OCT Spinal SystemMedicrea International SA20160—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+4K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+4K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+4K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+4K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+4K142741OASYS SystemStryker Corporation201537—
+4K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+4K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—