BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    TITANIUM SCREWS

    Reg #: 9680825 · FEI: 3002807827 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    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
    K955848

    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
    Pin, Fixation, Threaded JDW

    Proprietary Names

    TITANIUM SCREWS XCALIBER EXTERNAL FIXATOR BONE SCREWS XCALIBER BONE SCREWS ADULT LIMB RECONSTRUCTION SYSTEM PENNIG DYNAMIC WRIST FIXATOR PELVIC FIXATOR RADIOLUCENT WRIST FIXATOR SMALL BLUE D.A.F. PAEDIATRIC LIMB RECONSTRUCTION SYSTEM DYNAMIC AXIAL FIXATOR ELBOW FIXATOR ADVANCED LIMB RECONSTRUCTION SYSTEM MINIRAIL SYSTEM PREFIX FIXATOR PROCALLUS FIXATOR PENNIG MINIFIXATOR PERTROCHANTERIC FIXATOR

    Establishment Types

    Manufacture Medical Device