510(k) Report

Devices descending from K971819

464 later devices reach Epoch 2000 Neurological Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223273ASTRA Spine SystemSpinecraft, LLC20228—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+9K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+9K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+9K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+9K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+9K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+9K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+9K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+9K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+9K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+9K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+9K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+9K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+9K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+9K171651Excelsius GPSGlobus Medical, Inc.2017691
+9K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+9K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+10K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+10K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+10K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+10K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+10K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+10K241525ExcelsiusXR™Globus Medical, Inc.20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+10K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+10K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+10K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+10K243693NEO Pedicle Screw System™Neo Medical SA20240—
+10K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+10K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+10K240160EGPS Navigated InstrumentsAstura Medical20240—
+10K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+10K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+10K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+10K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+10K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+10K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+10K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+10K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+10K223558CUVIS-spineCurexo, Inc.20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+10K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+10K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+10K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+10K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+10K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+10K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+10K201569CUVIS-spineCurexo, Inc.20212—
+10K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+10K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+10K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+10K200896Solstice CCILife Spine, Inc.20200—
+10K191575ARx Spinal SystemLife Spine, Inc.201910—
+10K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+11K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+11K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+11K260810Anteralign LS coverplateTyber Medical, LLC20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+11K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+11K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+11K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—