BEUDAMED
    FDA Registration Active 🇺🇸 United States

    280.651S

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K964259

    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
    Device, Fixation, Proximal Femoral, Implant JDO
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    280.651S 280.270S 280.710S 280.720S 280.275S 280.715S 280.725S 280.340S 280.290S 280.685S 280.295S 280.255S 280.745S 280.315S 280.310S 280.730S 280.335S 280.265S 280.740S 280.325S 280.680S 280.690S 280.285S 280.301S 280.695S 280.665S 280.345S 280.280S 280.330S 280.660S 280.735S 280.260S 280.320S 280.701S 280.675S 280.670S 280.655S 280.305S 280.705S 280.251S

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)