BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Shoulder

    Reg #: 3004513872 · FEI: 3004513872 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FIVE STAR MANUFACTURING, INC.
    Registration Number
    3004513872
    FEI Number
    3004513872
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    163 SAMUEL BARNET BLVD.
    City
    NEW BEDFORD
    State
    MA
    ZIP
    02745
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103404

    Owner / Operator

    Firm Name
    FIVE STAR MANUFACTURING, INC.
    Operator Number
    9061981
    Address
    163 SAMUEL BARNET BLVD., --
    City
    New Bedford
    State
    MA
    Postal Code
    02745
    Country
    US
    Correspondent
    DAVID A CABRAL

    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

    Proprietary Names

    Shoulder

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)