510(k) Report

Devices descending from K012456

446 later devices reach Sodem High Speed System (Electric) (Ear, Nose, and Throat) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+6K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200896Solstice CCILife Spine, Inc.20200—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—