BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D

    Reg #: 2183449 · FEI: 2183449 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ORTHOFIX US LLC
    Registration Number
    2183449
    FEI Number
    2183449
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3451 Plano Parkway
    City
    Lewisville
    State
    TX
    ZIP
    75056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121148

    Owner / Operator

    Firm Name
    Orthofix US LLC
    Operator Number
    10028162
    Address
    3451 Plano Parkway
    City
    Lewisville
    State
    TX
    Postal Code
    75056
    Country
    US

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Sacroiliac Joint Fixation OUR

    Proprietary Names

    SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility