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
+4K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K120899Range Spinal System, Unit RodK2m, Inc.201235—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223852VySpan™ PCT SystemVy Spine, LLC20231—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—