BEUDAMED
    FDA Registration Active 🇫🇷 France

    ARROW reverse shoulder system

    Reg #: 3003898228 · FEI: 3003898228 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FH INDUSTRIE
    Registration Number
    3003898228
    FEI Number
    3003898228
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZI DE KERNEVEZ-6 RUE NOBEL
    City
    QUIMPER Finistere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K112193

    Owner / Operator

    Firm Name
    FH ORTHOPEDICS INC
    Operator Number
    9025586
    Address
    ORTHO EXPRESS LLC, 7327 E. TIERRA BUENA LANE
    City
    Scottsdale
    State
    AZ
    Postal Code
    85260
    Country
    US

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240117

    Products

    Device Name Product Code
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT

    Proprietary Names

    ARROW reverse shoulder system

    Establishment Types

    Manufacture Medical Device