BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROMOS MONOBLOCK STEM 02/35MM NON-CEM

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    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
    K063578

    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

    Proprietary Names

    PROMOS MONOBLOCK STEM 02/35MM NON-CEM PROMOS MONOBLOCK STEM 02/30MM NON-CEM PLUS PROMOS Inclination Set 20 MM PROMOS GLENOID 3-32 CEMENTED PROMOS GLENOID 4-32 CEMENTED PROMOS BODY 40MM PROMOS HUMERAL HEAD R27/+4 PROMOS HUMERAL HEAD R28/+4 PROMOS HUMERAL HEAD R27/+7 PROMOS MONOBLOCK STEM 02/40MM NON-CEM PROMOS HUMERAL HEAD R28/+7 PROMOS BODY 30MM PLUS PROMOS Inclination Set 22 MM PLUS PROMOS Inclination Set 26 MM PROMOS BODY 35MM PROMOS HUMERAL STEM 2.5 NON-CEM PLUS PROMOS Inclination Set 24 MM

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)