BEUDAMED
    FDA Registration Active 🇺🇸 United States

    X-STOP Kyphon

    Reg #: 2133687 · FEI: 3000206619 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    UNITY TOOL, INC.
    Registration Number
    2133687
    FEI Number
    3000206619
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11660 TROY LN
    City
    Osseo
    State
    MN
    ZIP
    55369
    Country
    US

    Regulatory Submissions

    PMA Number
    P040001

    Owner / Operator

    Firm Name
    UNITY TOOL, INC.
    Operator Number
    9025123
    Address
    11660 TROY LN., --
    City
    Maple Grove
    State
    MN
    Postal Code
    55369
    Country
    US
    Correspondent
    MICHAEL R VAN ESSEN

    Products

    Device Name Product Code
    Prosthesis, Spinous Process Spacer/Plate NQO

    Proprietary Names

    X-STOP Kyphon

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)