BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIGN IM Nail

    Reg #: 3034525 · FEI: 3003356728 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIGN Fracture Care International
    Registration Number
    3034525
    FEI Number
    3003356728
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    451 Hills St Ste B
    City
    RICHLAND
    State
    WA
    ZIP
    99354
    Country
    US

    Regulatory Submissions

    510(k) Number
    K022632

    Owner / Operator

    Firm Name
    SIGN Fracture Care International
    Operator Number
    9045925
    Address
    451 Hills Street, Suite B, --
    City
    Richland
    State
    WA
    Postal Code
    99354
    Country
    US
    Correspondent
    Robert J Schmitt

    Products

    Device Name Product Code
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    SIGN IM Nail 3.5mm Conical Washer HV Large Plate L-Handle Locking Bolt Step Screw, Series V Step Screw, Series IV Fx Plate System Cortical Screw, 3.5mm

    Establishment Types

    Manufacture Medical Device