BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stealthstation S8 System Platforms and StealthStation Cranial Software

    Reg #: 1723170 · FEI: 1000517638 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MEDTRONIC NAVIGATION, INC.
    Registration Number
    1723170
    FEI Number
    1000517638
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Medtronic Drive
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162309

    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
    Neurological Stereotaxic Instrument HAW
    Orthopedic Stereotaxic Instrument OLO
    Ear, Nose, And Throat Stereotaxic Instrument PGW

    Proprietary Names

    Stealthstation S8 System Platforms and StealthStation Cranial Software

    Establishment Types

    Manufacture Medical Device