510(k) Report

Devices descending from K061639

426 later devices reach Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200896Solstice CCILife Spine, Inc.20200—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+7K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+7K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412