BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pinnacle Multihole II Cup 54mm

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    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
    K000306

    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

    Proprietary Names

    Pinnacle Multihole II Cup 54mm Pinnacle Multihole II Cup 66mm Pinnacle Multihole II Cup 62mm Pinnacle Sector II Cup 50mm Pinnacle Multihole II Cup 50mm Pinnacle Multihole II Cup 48mm Pinnacle Sector II Cup 66mm Pinnacle Sector II Cup 48mm Pinnacle Multihole II Cup 60mm Pinnacle Multihole II Cup 58mm Pinnacle Sector II Cup 54mm Pinnacle Multihole II Cup 52mm Pinnacle Sector II Cup 58mm Pinnacle Sector II Cup 62mm Pinnacle Sector II Cup 64mm Pinnacle Multihole II Cup 64mm Pinnacle Sector II Cup 60mm PINNACLE 300 ACET CUP PINNACLE 100 ACET CUP Pinnacle Sector II Cup 52mm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)