BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ceramys™ femoral head system

    Reg #: 3012439458 · FEI: 3012439458 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Mathys AG Bettlach
    Registration Number
    3012439458
    FEI Number
    3012439458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Robert Mathys Strasse 5
    City
    Bettlach Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K241483

    Owner / Operator

    Firm Name
    ENCORE MEDICAL, L.P.
    Operator Number
    9002203
    Address
    9800 METRIC BLVD., --
    City
    Austin
    State
    TX
    Postal Code
    78758
    Country
    US
    Correspondent
    Sherri - Mellingen

    US Agent

    Business Name
    ENCORE MEDICAL, L.P.
    Contact Name
    Sherri Mellingen
    Address
    9800 Metric Blvd
    City
    Austin
    State
    TX
    ZIP
    78758
    Country
    US
    Email
    [email protected]
    Phone
    952 9136383

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    ceramys™ femoral head system

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)