BEUDAMED
    FDA Registration Active 🇺🇸 United States

    POLARCUP PE INSERT 51/28 NON-CEM

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    55
    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
    K070278

    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

    POLARCUP PE INSERT 51/28 NON-CEM POLARCUP PE INSERT 53/22 NON-CEM POLARCUP PE INSERT 63/28 NON-CEM POLARCUP PE INSERT 55/22 NON-CEM POLARCUP PE INSERT 47/28 NON-CEM POLARCUP PE INSERT 61/28 NON-CEM POLARCUP PE INSERT 67/28 NON-CEM POLARCUP SHELL TI-PLASMA 43 NON-CEM POLARCUP SHELL TI-PLASMA 67 NON-CEM POLARCUP SHELL 61 CEMENTED POLARCUP CORTICAL SCREW 4.5X52 NON CEM POLARCUP PE INSERT 59/22 NON-CEM POLARCUP CORTICAL SCREW 4.5X40 NON CEM POLARCUP SHELL TI-PLASMA 59 NON-CEM POLARCUP CORTICAL SCREW 4.5X44 NON CEM POLARCUP ANCHORING PEG (2 EACH) POLARCUP SHELL TI-PLASMA 61 NON-CEM POLARCUP PE INSERT 67/22 NON-CEM POLARCUP SHELL 53 CEMENTED POLARCUP CORTICAL SCREW 4.5X48 NON CEM POLARCUP SHELL 57 CEMENTED POLARCUP SHELL 45 CEMENTED POLARCUP PE INSERT 43/22 NON-CEM POLARCUP SHELL 55 CEMENTED POLARCUP PE INSERT 63/22 NON-CEM POLARCUP SHELL TI-PLASMA 65 NON-CEM POLARCUP PE INSERT 49/22 NON-CEM POLARCUP PE INSERT 57/22 NON-CEM POLARCUP PE INSERT 65/28 NON-CEM POLARCUP SHELL 49 CEMENTED POLARCUP PE INSERT 65/22 NON-CEM POLARCUP CORTICAL SCREW 4.5X55 NON CEM POLARCUP SHELL TI-PLASMA 57 NON-CEM POLARCUP SHELL 59 CEMENTED POLARCUP PE INSERT 55/28 NON-CEM POLARCUP PE INSERT 53/28 NON-CEM POLARCUP SHELL TI-PLASMA 53 NON-CEM POLARCUP SHELL TI-PLASMA 49 NON-CEM POLARCUP PE INSERT 45/22 NON-CEM POLARCUP SHELL TI-PLASMA 63 NON-CEM POLARCUP PE INSERT 47/22 NON-CEM POLARCUP PE INSERT 61/22 NON-CEM POLARCUP PE INSERT 57/28 NON-CEM POLARCUP SHELL 43 CEMENTED POLARCUP SHELL TI-PLASMA 47 NON-CEM POLARCUP PE INSERT 51/22 NON-CEM POLARCUP SHELL 51 CEMENTED POLARCUP SHELL TI-PLASMA 55 NON-CEM POLARCUP PE INSERT 49/28 NON-CEM POLARCUP PE INSERT 59/28 NON-CEM POLARCUP SHELL 63 CEMENTED POLARCUP SHELL TI-PLASMA 45 NON-CEM POLARCUP SHELL TI-PLASMA 51 NON-CEM POLARCUP CORTICAL SCREW 4.5X60 NON CEM POLARCUP SHELL 47 CEMENTED

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)