BEUDAMED
    FDA Registration Active 🇫🇷 France

    Uni FB PE-insert 2/11 mm

    Reg #: 3011274144 · FEI: 3011274144 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    60
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WESTLAKE PLASTICS EUROPE
    Registration Number
    3011274144
    FEI Number
    3011274144
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 rue de Maestricht
    City
    TOURCOING Nord
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K203341

    Owner / Operator

    Firm Name
    WESTLAKE PLASTICS EUROPE
    Operator Number
    10048274
    Address
    2 rue de Maestricht
    City
    TOURCOING
    State
    Nord
    Postal Code
    59200
    Country
    FR

    US Agent

    Business Name
    Westlake Plastics Company
    Contact Name
    Yared Mengistu
    Address
    490 W. Lenni Road
    City
    Lenni
    State
    PA
    ZIP
    19052
    Country
    US
    Email
    [email protected]
    Phone
    610 4591000 ext. 2326

    Products

    Device Name Product Code
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    Uni FB PE-insert 2/11 mm Uni FB tibial trial insert 1/12mm Uni FB PE-insert 2/14mm Uni FB tibial insert 2/10mm Uni FB PE-insert 1/11 mm Uni FB tibial trial insert 0/11mm Uni FB tibial insert 2/9mm Uni FB tibial insert 3/11mm Uni FB PE-insert 4/11 mm Uni FB trial insert 3/9mm Uni FB PE-insert 0/8mm Uni FB PE-insert 3/10 mm Uni FB tibial trial 4/8mm Uni FB tibial trial insert 3/12mm Uni FB trial insert 1/8mm Uni FB tibial insert 1/10mm Uni FB PE-insert 4/14mm Uni FB PE-insert 3/14mm Uni FB tibial trial insert 4/12mm Uni FB PE-insert 4/9 mm Uni FB PE-insert 1/12mm Uni FB tibial trial insert 1/14mm Uni FB trial insert 4/9mm Uni FB tibial trial insert 0/9mm Uni FB PE-insert 2/12mm Uni FB PE-insert 3/12mm Uni FB tibial insert 1/11mm Uni FB trial insert 3/8mm Uni FB trial insert 2/8mm Uni FB tibial insert 4/11mm Uni FB tibial trial insert 0/10mm Uni FB tibial trial insert 2/12mm Uni FB PE-insert 3/11 mm Uni FB PE-insert 2/8 mm Uni FB tibial trial insert 0/12mm Uni FB PE-insert 0/14mm Uni FB PE-insert 4/10 mm Uni FB PE-insert 0/9mm Uni FB PE-insert 0/10mm Uni FB PE-insert 1/9 mm Uni FB PE-insert 3/8 mm Uni FB tibial insert 3/10mm Uni FB trial insert 1/9mm Uni FB PE-insert 0/11mm Uni FB PE-insert 1/14mm Uni FB PE-insert 4/8 mm Uni FB PE-insert 1/10 mm Uni FB PE-insert 2/9 mm Uni FB tibial insert 4/10mm Uni FB tibial trial insert 2/14mm Uni FB PE-insert 1/8 mm Uni FB PE-insert 0/12mm Uni FB tibial trial insert 0/8mm Uni FB PE-insert 4/12mm Uni FB PE-insert 3/9 mm Uni FB PE-insert 2/10 mm Uni FB tibial trial insert 3/14mm Uni FB tibial trial insert 0/14mm Uni FB tibial insert 2/11mm Uni FB tibial trial insert 4/14mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)