BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Total Shoulder Prosthesis Foundation Total Shoulder Primary Humeral Stem

    Reg #: 1649518 · FEI: 3001236277 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1649518
    FEI Number
    3001236277
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3125 Wichita Court
    City
    Fort Worth
    State
    TX
    ZIP
    76140
    Country
    US

    Regulatory Submissions

    510(k) Number
    K950651

    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
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    Total Shoulder Prosthesis Foundation Total Shoulder Primary Humeral Stem Total Shoulder Prosthesis Foundation Total Shoulder Standard Humeral Head Total Shoulder Prosthesis Foundation Total Shoulder Glenoid Total Shoulder Prosthesis Foundation Offset Humeral Head

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)