BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Humeris® 135 Shoulder System

    Reg #: 3014128390 · FEI: 3014128390 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Fx Shoulder Solutions Inc.
    Registration Number
    3014128390
    FEI Number
    3014128390
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15920 Addison Rd, Suite 200
    City
    Addison
    State
    TX
    ZIP
    75001
    Country
    US

    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

    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

    Develop Specifications But Do Not Manufacture At This Facility