BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fisch Modified Total; Fisch Spandrel II Total with Shoe

    Reg #: 1045254 · FEI: 1045254 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDTRONIC XOMED, INC.
    Registration Number
    1045254
    FEI Number
    1045254
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6743 SOUTHPOINT DR. NORTH
    City
    Jacksonville
    State
    FL
    ZIP
    32216
    Country
    US

    Regulatory Submissions

    510(k) Number
    K823442

    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
    Porous Polyethylene Ossicular Replacement LBM

    Proprietary Names

    Fisch Modified Total; Fisch Spandrel II Total with Shoe Various Polyethylene Ossic Replace

    Establishment Types

    Manufacture Medical Device