BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    COMPREHENSIVE PRIMARY SHOULDER STEMS

    Reg #: 3012319330 · FEI: 3012319330 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Zimmer Orthopedics Manufacturing Limited-Galway
    Registration Number
    3012319330
    FEI Number
    3012319330
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Deerpark Industrial Estate
    City
    Oranmore Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K060692

    Owner / Operator

    Firm Name
    ZIMMER, INC.
    Operator Number
    1822565
    Address
    345 E. Main Street, --
    City
    Warsaw
    State
    IN
    Postal Code
    46580
    Country
    US

    US Agent

    Business Name
    Zimmer Biomet
    Contact Name
    Holly Seppanen
    Address
    1800 West Center Street
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    952 8470494

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF

    Proprietary Names

    COMPREHENSIVE PRIMARY SHOULDER STEMS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)