510(k) Report

Devices descending from K914571

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K201327NavLock TrackersMedtronic Navigation20202—
+9K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+9K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+9K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+9K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+9K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+9K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+9K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+9K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+9K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+9K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+9K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+9K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+9K182721Choice Spine Navigation SystemChoicespine, LP20192—
+9K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+9K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+9K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+9K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+9K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+9K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+9K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+9K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+9K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+9K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K171321K2M Navigation InstrumentsK2m201711
+9K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+9K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+9K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+9K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+9K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+9K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+9K150620740 SelectCas Medical Systems, Inc.201501
+9K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+9K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+9K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+10K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+10K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+10K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+10K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+10K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+10K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+10K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+10K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+10K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+10K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+10K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+10K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+10K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+10K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+10K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+10K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+10K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+10K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+10K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+10K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+10K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+10K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+10K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+10K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+10K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+10K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+10K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+10K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+10K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+10K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K223273ASTRA Spine SystemSpinecraft, LLC20228—