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    K Number
    K981855
    Device Name
    PRINCE MEDICAL CEMENT PLUG
    Manufacturer
    PRINCE MEDICAL, INC.
    Date Cleared
    1998-08-10

    (76 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRINCE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Prince Medical Cement Plug is indicated for use with cemented total hip or endoprosthetic femoral components to : - 1. Prevent the bone cement from distal migration during its insertion. - 1. Increase the pressure of the cement during cement and femoral component insertion to facilitate bone penetration and distribution of the cement.
    Device Description
    The Prince Medical Cement Plug consists of various sizes and is made from Medical Grade Ultra High Molecular Weight Polyethylene (UHMWPE). The component is produced in two outside diameters and is introduced into the medullary canal using a stainless steel inserting tool. Under this premarket notification, the device is available in 18.5 and 25.0mm outside diameter.
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