BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ADVANTAGE® HUMERAL HEAD SIZE 44mm x 15mm

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    25
    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
    K984541

    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, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT

    Proprietary Names

    ADVANTAGE® HUMERAL HEAD SIZE 44mm x 15mm ADVANTAGE® ECCENTRIC HEAD SIZE 48mm x 21mm ADVANTAGE® HUMERAL HEAD SIZE 40mm x 18mm ADVANTAGE® ECCENTRIC HEAD SIZE 52mm x 18mm ADVANTAGE® HUMERAL HEAD SIZE 40mm x 15mm ADVANTAGE® ECCENTRIC HEAD SIZE 56mm x 21mm ADVANTAGE® ECCENTRIC HEAD SIZE 44mm x 21mm ADVANTAGE® HUMERAL HEAD SIZE 56mm x 18mm ADVANTAGE® ECCENTRIC HEAD SIZE 48mm x 18mm ADVANTAGE® ECCENTRIC HEAD SIZE 44mm x 18mm ADVANTAGE® HUMERAL HEAD SIZE 48mm x 15mm ADVANTAGE® HUMERAL HEAD SIZE 44mm x 18mm ADVANTAGE® ECCENTRIC HEAD SIZE 52mm x 21mm ADVANTAGE® HUMERAL HEAD SIZE 56mm x 15mm ADVANTAGE® HUMERAL HEAD SIZE 48mm x 18mm ADVANTAGE® ECCENTRIC HEAD SIZE 56mm x 18mm ADVANTAGE® HUMERAL HEAD SIZE 52mm x 18mm ADVANTAGE® HUMERAL HEAD SIZE 52mm x 15mm ADVANTAGE® HUMERAL HEAD SIZE 44mm x 21mm ADVANTAGE® HUMERAL HEAD SIZE 56mm x 21mm ADVANTAGE® HUMERAL HEAD SIZE 52mm x 21mm ADVANTAGE® HUMERAL HEAD SIZE 40mm x 21mm ADVANTAGE® HUMERAL HEAD SIZE 48mm x 21mm GLOBAL FX GLOBAL ADVANTAGE

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)