BEUDAMED
    FDA Registration Active 🇫🇷 France

    Humeris® 135 Shoulder System

    Reg #: 3009532798 · FEI: 3009532798 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Fx Shoulder Solutions SAS
    Registration Number
    3009532798
    FEI Number
    3009532798
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1663 rue de Majornas
    City
    Viriat Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K222936

    Owner / Operator

    Firm Name
    FX Shoulder Solutions
    Operator Number
    10039598
    Address
    1663 rue de Majornas
    City
    Viriat
    State
    FR-NOTA
    Postal Code
    01440
    Country
    FR
    Correspondent
    Sabrina Gental

    Products

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

    Proprietary Names

    Humeris® 135 Shoulder System

    Establishment Types

    Manufacture Medical Device