BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COLIGNE AG

    Reg #: 1724670 · FEI: 3002840549 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NEW ROAD ENTERPRISES, INC.
    Registration Number
    1724670
    FEI Number
    3002840549
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1951 33RD ST.
    City
    BOULDER
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181963

    Owner / Operator

    Firm Name
    New Road Enterprises / Young
    Operator Number
    9039483
    Address
    1951 33RD ST., --
    City
    Boulder
    State
    CO
    Postal Code
    80301
    Country
    US
    Correspondent
    David - Young

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    COLIGNE AG

    Establishment Types

    Manufacture Medical Device