BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PLUS USA PMMA Spacr

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3002907620
    FEI Number
    3002907620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1700 College Blvd.
    City
    West Memphis
    State
    AR
    ZIP
    72301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031165

    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, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    PLUS USA PMMA Spacr PLUS IPM Centralizer 12MM PLUS IPM Centralizer 15MM PLUS IPM Centralizer 11MM PLUS USA PMMA Centralizer 10mm 10MM PLUS IPM Centralizer 13MM PLUS IPM Centralizer 17MM PLUS IPM Centralizer 16MM PLUS IPM Centralizer 14MM

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)