BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 2 97mm

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    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
    K030122

    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, Uncemented LWJ

    Proprietary Names

    FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 2 97mm FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 8 140mm FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 6 127mm FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 6 150mm FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 3 135mm FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 3 108mm FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 2 130mm FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 5 145mm FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 8 160mm FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 7 155mm FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 4 140mm FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 4 114mm FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 5 121mm FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 7 133mm SUMMIT BASIC PRESS FIT

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)