510(k) Report

Devices descending from K002733

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K170647Connector SystemOrthofix, Inc.201718—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+3K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K161149PASS OCT Spinal SystemMedicrea International SA20160—
+3K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K160756PASS OCT Spinal SystemMedicrea International SA20160—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K153169PASS OCT Patient Specific RodsMedicrea International20164—
+3K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+3K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+3K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+3K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+3K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+3K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K120998Solstice Cross ConnectorLife Spine20121—
+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—
+3K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+3K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+3K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+3K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+3K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+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—
+3K101183Modification to: Oasys SystemStryker Spine20100—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K093670Modification to: Oasys SystemStryker Spine201041Class I
+3K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+3K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+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—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230614Cortium™Ulrich Medical USA20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223852VySpan™ PCT SystemVy Spine, LLC20231—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—