BEUDAMED
    FDA Registration Active 🇺🇸 United States

    External Frame Circular

    Reg #: 3021680719 · FEI: 3021680719 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QUALITEX INC.
    Registration Number
    3021680719
    FEI Number
    3021680719
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4185 E. Park 30 Drive
    City
    Columbia City
    State
    IN
    ZIP
    46725
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212895

    Owner / Operator

    Firm Name
    Qualitex Inc.
    Operator Number
    10084373
    Address
    4185 E. Park 30 Drive
    City
    Columbia City
    State
    IN
    Postal Code
    46725
    Country
    US

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    External Frame Circular

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)