BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABLE MEDICAL DEVICES

    Reg #: 3014680795 · FEI: 3014680795 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABLE MEDICAL DEVICES
    Registration Number
    3014680795
    FEI Number
    3014680795
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    512 Fourth Street
    City
    Gwinn
    State
    MI
    ZIP
    49841
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132126

    Owner / Operator

    Firm Name
    Able Medical Devices
    Operator Number
    10058122
    Address
    512 Fourth Street
    City
    Gwinn
    State
    MI
    Postal Code
    49841
    Country
    US
    Correspondent
    Halie Gibson

    Products

    Device Name Product Code
    System, Facet Screw Spinal Device MRW

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)