BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACETABULAR SHELL GRIPTION? 100 54mm OD

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    3

    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
    K090998

    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, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

    Proprietary Names

    ACETABULAR SHELL GRIPTION? 100 54mm OD Pinn 100 w/Gription 62mm ACETABULAR SHELL GRIPTION? 100 48mm OD ACETABULAR SHELL GRIPTION? 100 58mm OD ACETABULAR SHELL GRIPTION? 100 46mm OD ACETABULAR SHELL GRIPTION? 100 64mm OD ACETABULAR SHELL GRIPTION? 100 62mm OD ACETABULAR SHELL GRIPTION? 100 66mm OD ACETABULAR SHELL GRIPTION? 100 44mm OD Pinn 100 w/Gription 66mm Pinn 100 w/Gription 50mm Pinn 100 w/Gription 54mm Pinn 100 w/Gription 58mm ACETABULAR SHELL GRIPTION? 100 50mm OD ACETABULAR SHELL GRIPTION? 100 52mm OD ACETABULAR SHELL GRIPTION? 100 60mm OD Pinn 100 w/Gription 52mm Pinn 100 w/Gription 48mm ACETABULAR SHELL GRIPTION? 100 56mm OD Pinn 100 w/Gription 64mm PINN 100 W/GRIPTION Pinn 100 w/Gription 60mm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)