BEUDAMED
    FDA Registration Active 🇫🇷 France

    FX V135 Shoulder Prosthesis

    Reg #: 3011943495 · FEI: 3011943495 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PRECIMADE
    Registration Number
    3011943495
    FEI Number
    3011943495
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20 av Arsene d'Arsonval
    City
    Bourg en Bresse Ain
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K213117

    Owner / Operator

    Firm Name
    Precimade
    Operator Number
    10054968
    Address
    161 Avenue Franklin Roosevelt
    City
    Decines
    State
    Auvergne-Rhone-Alpes
    Postal Code
    69150
    Country
    FR
    Correspondent
    Marc GAGNANT

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Shoulder Prosthesis, Reverse Configuration PHX

    Proprietary Names

    FX V135 Shoulder Prosthesis

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)