BEUDAMED
    FDA Registration Active 🇫🇷 France

    Full Wedge Lateralized and Augmented Baseplates

    Reg #: 3009532798 · FEI: 3009532798 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    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
    K240278

    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
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    Full Wedge Lateralized and Augmented Baseplates

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device