510(k) Report

Devices descending from K030103

658 later devices reach Summit Oct Spinal System Minipolyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+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—
+3K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K113346Neon SystemUlrich GmbH & Co. KG20121—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+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—
+3K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+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—
+3K101084Caspian Spinal SystemK2m, Inc.201062—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+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—
+3K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+3K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+3K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+3K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+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—
+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—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+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—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+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—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K173508Everest Spinal SystemK2m20189—
+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—
+4K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+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—
+4K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+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—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150753OASYS SystemStryker Corporation201534—
+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—
+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—