BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ototronix, LLC (Minnesota)

    Reg #: 3012118649 · FEI: 3012118649 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Ototronix, LLC (Minnesota)
    Registration Number
    3012118649
    FEI Number
    3012118649
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5000 Township Pkwy
    City
    White Bear Township
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140644
    PMA Number
    P010023

    Owner / Operator

    Firm Name
    Ototronix, LLC
    Operator Number
    10031730
    Address
    5000 Township Parkway
    City
    Saint Paul
    State
    MN
    Postal Code
    55110
    Country
    US
    Correspondent
    Brant Newman

    Products

    Device Name Product Code
    Implant, Hearing, Active, Middle Ear, Partially Implanted MPV
    Cement, Ear, Nose And Throat NEA

    Proprietary Names

    Maxum ProCem

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device