510(k) Report

Devices descending from K171651

69 later devices reach Excelsius GPS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+1K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+1K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+1K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+1K241525ExcelsiusXR™Globus Medical, Inc.20250—
+1K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+1K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+1K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+1K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+1K240160EGPS Navigated InstrumentsAstura Medical20240—
+1K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+1K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+1K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+1K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+1K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+1K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+1K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+1K223558CUVIS-spineCurexo, Inc.20230—
+1K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+1K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+1K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+1K201569CUVIS-spineCurexo, Inc.20212—
+1K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+1K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+1K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+1K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+1K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+1K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+2K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+2K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+2K233256Robotic Integration InstrumentsDePuy Synthes20240—
+2K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+2K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+2K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K222698CUVIS-spineCurexo, Inc.20220—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—