BEUDAMED
    FDA Registration Active 🇺🇸 United States

    D-RAD Smart Pack

    Reg #: 1043653 · FEI: 1043653 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ONYX MEDICAL LLC
    Registration Number
    1043653
    FEI Number
    1043653
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1800 North Shelby Oaks Drive
    City
    MEMPHIS
    State
    TN
    ZIP
    38134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132296

    Owner / Operator

    Firm Name
    Elos Medtech Onyx
    Operator Number
    9002922
    Address
    1800 N Shelby Oaks Dr, --
    City
    Memphis
    State
    TN
    Postal Code
    38134
    Country
    US
    Correspondent
    Jodie L Gilmore

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    D-RAD Smart Pack

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)