BEUDAMED
    FDA Registration Active 🇫🇷 France

    Quantum® Total Ankle Prosthesis

    Reg #: 3010141347 · FEI: 3010141347 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CF PLASTIQUES
    Registration Number
    3010141347
    FEI Number
    3010141347
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43 rue des bruyeres
    City
    PUSIGNAN Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K191380

    Owner / Operator

    Firm Name
    CF PLASTIQUES
    Operator Number
    10043686
    Address
    43 rue des bruyeres
    City
    PUSIGNAN
    State
    Rhone
    Postal Code
    69330
    Country
    FR
    Correspondent
    Floriane DEVOGE

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Michael van der Woude
    Address
    2500 Bee Cave Road, Bldg 1, Suite 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN

    Proprietary Names

    Quantum® Total Ankle Prosthesis

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)