BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDTRONIC NAVIGATION, INC.

    Reg #: 1723170 · FEI: 1000517638 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    102
    Establishment Types
    3
    Classifications
    25

    Registration Details

    Registration Name
    MEDTRONIC NAVIGATION, INC.
    Registration Number
    1723170
    FEI Number
    1000517638
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200 Medtronic Drive
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133665

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    System, Nuclear Magnetic Resonance Imaging LNH
    Orthopedic Stereotaxic Instrument OLO
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Stylet, Surgical, General & Plastic Surgery GAH
    Neurological Stereotaxic Instrument HAW
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    System, Image Processing, Radiological LLZ
    Pump, Infusion FRN
    Powered Laser Surgical Instrument GEX
    Drape, Surgical, Exempt PUI
    Neurosurgical Laser With Mr Thermography ONO
    Interventional Fluoroscopic X-Ray System OWB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Hammer, Surgical FZY
    Accessories, Catheter KGZ
    Wrap, Sterilization FRG
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Retractor GAD
    Instrument, Manual, Surgical, General Use MDM
    Instrument, Surgical, Non-Powered HAO
    Motor, Drill, Pneumatic HBB
    Motor, Drill, Electric HBC

    Proprietary Names

    Stealth AXiS™ ENT Clinical Application STEALTH AXIS™ Visualase StealthStation Universal Attachment StealthStation Fluoro Nav Module FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM Navigated CD HORIZON SOLERA Screwdrivers and Taps CD HORIZON SOLERA Spinal System PlasmaBlade X 3S LIGHT Navlock Black and Blue Trackers Stealth Viz Software Visualase Thermal Therapy System Aquamantys SBS 5 Sheathed Bipolar Sealer (23-312-1) Aquamantys Mini EVS 3.4 Epidural Vein Sealer (23-314-1) Aquamantys Epidural Vein Sealer (23-121-1) Aquamantys 2.3 Bipolar Sealer (23-113-1); StealthStation Advanced Contour Registration StealthStation Cranial Software, v3.1.5 (9735585) StealthStation Orthopaedic Trauma Stealth™ Spine Clamps ModuLeX™ Shank Mounts O-arm Equipment Drape Surgical drape and drape accessories StealthStation S8 ENT Software Stealthstation S8 Spine Software v1.3 Immerge Image Correlation V2 VISUALASE THERMAL THERAPY SYSTEM PEAK PlasmaBlade 3S (Model Number: PS210-030S, PS210-030S-SP, PS210-030SE) StealthStation (Drill attachment) NavLock Trackers Polestar N-20 StealthStation Cranial Software v1.3 GoldenEye Micro-Magnetic Tracking Mazor X Visualase™ V2 MRI-Guided Laser Ablation System O-arm™ O2 imaging system StealthStation Imageless Knee Module StealthStation FlexENT StealthStation S8 ENT Software 1.3 StealthStation AxiEM Imageless Knee Module Manual surgical instrument for general use Slap Hammer AQUAMANTYS SS4 BIPOLAR SEALER, MODEL 23-121-1 StealthStation System StealthConnect Remote Viewing, Planning and Collaboration System StealthStation S8 Spine Software Ziehm StealthStation™ Spinous Process Clamps O-Arm O2 Imaging System StealthStation ENT Application neurological stereotaxic instrument StealthStation System with StealthStation Cranial Software O-Arm Imaging System StealthStation Hip Module StealthStation AxiEM Imageless Hip Visualase (9735563) PEAK PlasmaBlade Tonsil (PS300-001, PS300-001E, PS300-003, SP300-003E) StealthStation S8 Cranial v2 Mazor X System Mazor X Stealth Edition Steritite Sealed Containers StealthStation Cranial Software v3.1.1 StealthStation Synergy Cranial S7 Software v.2.2.8, RETRACTOR RadiaLux™ Spacekeeper PEAK PlasmaBlade Needle (Model Number: PS200-001, PS200-001-SP, PS200-001E, PS200-001SPE) StealthStation™ Cranial Software FUSION Compact Navigation System O-Arm StealthStation Laser Registration Device Neurological Stereotaxic Instrument MICRO-FRANCE Manual Surgical Instr MULTIPLE Manual Surgical Instruments KyphX Handle; Introducer XOMED EM ENT Navigated Suction ONO Pocket sizer DBS Tunneling tool Tunneling Tool Accessory Kit SenSight™ Visualase™ Cooled Laser Applicator System StealthStation Wireless Mouse Navigated Vertex Select Drill Bit Navigated Vertex Select Threaded Driver Navigated Vertex Select Tap Stealthstation S8 System Platforms and StealthStation Cranial Software Stealth AXiS Neurological Sterotaxic Instrument Mazor X System (Mazor X Stealth Edition) PEAK PULSAR II GENERATOR MODEL PS100-102 Stealth Autoguide Midas Rex Legend Depth Stop System StealthStation 3D for C-Arm StealthStation Knee Module Reducing Tube 9735733 3.2mm Cranial Tube Set 9735998 Cranial Reducing Reducing Tube 9735734 4mm Cranial Reducing Tube 9735732 1.7mm Cranial NavLock Trackers and Robotic Reference Frame StealthStation Natrex

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device