510(k) Report

Devices descending from K914571

884 later devices reach Neurotrac II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+10K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+10K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+10K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+10K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+10K213515WesperO2Wesper, Inc.20220—
+10K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+10K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+10K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+10K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+10K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+10K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+10K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+10K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+10K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+10K202851Spo2 SensorJkh USA, LLC20201—
+10K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+10K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+10K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+10K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+10K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+10K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+10K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+10K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+10K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+10K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+10K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+10K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+10K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+10K173045OximeterShenzhen Greatmade Tech Limited20180—
+10K171651Excelsius GPSGlobus Medical, Inc.2017691
+10K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+10K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+10K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+11K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+11K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+11K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+11K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+11K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+11K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+11K252981EmbraceMiniEmpatica S.r.l.20251—
+11K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+11K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+11K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+11K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+11K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+11K241525ExcelsiusXR™Globus Medical, Inc.20250—
+11K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+11K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+11K250515EpiMonitorEmpatica S.r.l.20250—
+11K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+11K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+11K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+11K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+11K243693NEO Pedicle Screw System™Neo Medical SA20240—
+11K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+11K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+11K240160EGPS Navigated InstrumentsAstura Medical20240—
+11K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+11K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+11K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+11K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+11K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+11K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+11K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+11K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+11K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+11K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+11K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+11K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+11K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+11K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+11K223558CUVIS-spineCurexo, Inc.20230—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+11K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+11K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+11K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+11K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+11K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+11K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+11K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+11K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+11K201569CUVIS-spineCurexo, Inc.20212—
+11K210539CoreLink Midline Fixation SystemCorelink, LLC20214—