BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Woods Incus Stapes

    Reg #: 1037007 · FEI: 1037007 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GYRUS ACMI, INC.
    Registration Number
    1037007
    FEI Number
    1037007
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2925 Appling Rd
    City
    BARTLETT
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K861369

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    Products

    Device Name Product Code
    Prosthesis, Partial Ossicular Replacement ETB

    Proprietary Names

    Woods Incus Stapes Goldenberg Incus Stapes Meyerhoff Incus Kartush Incus Stapes Grote Incus Stapes

    Establishment Types

    Manufacture Medical Device