BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arthrex Univers II Shoulder Prosthesis

    Reg #: 3009423112 · FEI: 3009423112 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Arthrex Logistic Center
    Registration Number
    3009423112
    FEI Number
    3009423112
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14550 Plantation Road
    City
    Fort Myers
    State
    FL
    ZIP
    33912
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103466

    Owner / Operator

    Firm Name
    ARTHREX, INC.
    Operator Number
    1220287
    Address
    1370 CREEKSIDE BLVD., --
    City
    Naples
    State
    FL
    Postal Code
    34108
    Country
    US
    Correspondent
    Barry Dietz

    Products

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

    Proprietary Names

    Arthrex Univers II Shoulder Prosthesis

    Establishment Types

    Manufacture Medical Device