510(k) Report

Devices descending from K153203

112 later devices reach Navigation Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+1K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+1K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+1K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+1K183381Navigation Enabled InstrumentsStryker20191—
+1K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+1K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+1K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+1K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+1K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+1K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+2K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+2K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+2K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+2K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+2K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K210472SPINEART Navigation Instrument SystemSpineart20215—
+2K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+2K201006K2M Navigation InstrumentsK2m, Inc.20200—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+2K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+2K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+2K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200896Solstice CCILife Spine, Inc.20200—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K230989Rod Registration FrameNu Vasive, Incorporated20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—