BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kyphon Xpander II Inflatable Bone Tamp

    Reg #: 3003120897 · FEI: 3003120897 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Registration Number
    3003120897
    FEI Number
    3003120897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4340 Swinnea Road
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101864

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Tamp HXG
    Arthroscope HRX

    Proprietary Names

    Kyphon Xpander II Inflatable Bone Tamp

    Establishment Types

    Manufacture Medical Device