510(k) Report

Devices descending from K041203

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K173047The Solstice OCT SystemLife Spine, Inc.20180—
+3K173508Everest Spinal SystemK2m20189—
+3K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+3K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+3K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+3K161149PASS OCT Spinal SystemMedicrea International SA20160—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K160756PASS OCT Spinal SystemMedicrea International SA20160—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K153169PASS OCT Patient Specific RodsMedicrea International20164—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+3K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142741OASYS SystemStryker Corporation201537—
+3K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+3K120998Solstice Cross ConnectorLife Spine20121—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K120899Range Spinal System, Unit RodK2m, Inc.201235—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K113346Neon SystemUlrich GmbH & Co. KG20121—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K113654CaspianK2m, Inc.201244—
+3K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+3K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc.2008124—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501