BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kyphon Xpander II KyphoPakTray

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101864

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Tamp HXG
    Arthroscope HRX

    Proprietary Names

    Kyphon Xpander II KyphoPakTray Kyphon Xpander II Inflatable Bone Tamps KyphoPak Xpander II First Fracture and Additonal Fracture Trays

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)