BEUDAMED
    FDA Registration Active 🇵🇦 Panama

    ORTOSISTEMAS, S.A.

    Reg #: 3012329552 · FEI: 3012329552 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTOSISTEMAS, S.A.
    Registration Number
    3012329552
    FEI Number
    3012329552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calle Elida Diez, Urbanizacion El Carmen. Bella Vista
    City
    Panama
    Country
    PA

    Regulatory Submissions

    510(k) Number
    K052776

    Owner / Operator

    Firm Name
    Ortosistemas, S.A.
    Operator Number
    10083460
    Address
    Calle Elida Diez, Urbanizacion El Carmen. Bella Vista
    City
    Panama
    State
    PA-8
    Postal Code
    238-0816
    Country
    PA

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Washer, Bolt Nut HTN

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device