510(k) Report

Devices descending from K031511

902 later devices reach Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+6K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+6K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+6K140734Nextgen Altius Oct SystemEbi, LLC20140—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+6K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+6K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+6K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+6K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+6K113346Neon SystemUlrich GmbH & Co. KG20121—
+6K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K261408SABER-XA SystemElevation Spine20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233300POWEReam 1/4 DriveStryker Instruments20231—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231515MySpine Cervical GuidesMedacta International S.A.20230—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+7K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230614Cortium™Ulrich Medical USA20230—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—