BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    GALAXY UNYCO

    Reg #: 9680825 · FEI: 3002807827 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTHOFIX SRL
    Registration Number
    9680825
    FEI Number
    3002807827
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA DELLE NAZIONI 9
    City
    BUSSOLENGO Verona
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K142052

    Owner / Operator

    Firm Name
    ORTHOFIX SRL
    Operator Number
    9011783
    Address
    VIA DELLE NAZIONI 9, --
    City
    BUSSOLENGO
    State
    Verona
    Postal Code
    37012
    Country
    IT
    Correspondent
    ELVIRA - TACCARELLI

    US Agent

    Business Name
    Orthofix US LLC
    Contact Name
    Amira Milutinovic
    Address
    3451 Plano Pkwy
    City
    Lewisville
    State
    TX
    ZIP
    75056
    Country
    US
    Email
    [email protected]
    Phone
    214 9372196

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    GALAXY UNYCO GALAXY UNYCO DIAPHYSEAL TIBIA KIT

    Establishment Types

    Manufacture Medical Device