BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIGN IM Nail

    Reg #: 3034525 · FEI: 3003356728 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    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
    K163589

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    SIGN IM Nail Distal Extension Center Section Shoulder Cap Screw Alignment Pin Drill Guide Proximal Target Arm Adjustment Screw Cannula

    Establishment Types

    Manufacture Medical Device