510(k) Report

Devices descending from K982322

692 later devices reach Synthes Spine Occipital-Cervical Plate/Rod and Hook System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+3K050979S4 Spinal SystemAesculap, Inc.200567—
+3K042100Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorBlackstone Medical, Inc.2004139—
+3K033980Blackstone Ascent Poct System Hooks (System Modification)Blackstone Medical, Inc.2004134—
+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—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+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—
+4K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+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—
+4K231654NorthStar OCT SystemSeaspine, Inc.20230—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170647Connector SystemOrthofix, Inc.201718—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+4K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K161149PASS OCT Spinal SystemMedicrea International SA20160—
+4K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+4K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+4K160756PASS OCT Spinal SystemMedicrea International SA20160—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+4K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+4K140734Nextgen Altius Oct SystemEbi, LLC20140—
+4K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+4K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+4K130877Expedium Spine SystemMedos International SARL20138—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K120998Solstice Cross ConnectorLife Spine20121—
+4K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+4K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+4K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113346Neon SystemUlrich GmbH & Co. KG20121—
+4K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+4K111719Oasys Spinal SystemStryker Spine201239—
+4K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+4K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+4K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+4K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+4K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+4K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+4K101183Modification to: Oasys SystemStryker Spine20100—
+4K101070Expedium Spine SystemMedos International SARL20102601
+4K093670Modification to: Oasys SystemStryker Spine201041Class I
+4K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+4K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+4K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+4K080143Modification to Stryker Spine Oasys SystemStryker Spine200843—
+4K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+4K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+4K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+4K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+4K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—