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510(k) Data Aggregation

    K Number
    K955137
    Device Name
    IM C-MENT ACETABULAR CAP
    Date Cleared
    1996-10-10

    (332 days)

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

    IMPLANT IDEAS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IM C-Ment Acetabular Cup will be used in indications which are the same as that for other acetabular components of cemented total hip replacement systems. Specifically, the IM C-Ment Acetabular Cup is intended to resurface the acetabular socket in cases of femoral head and neck fractures, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed prostheses. The IM C-Ment Acetabular Cup is intended to be used in cemented applications only.
    Device Description
    The IM C-Ment Acetabular Cup is an all-polyethylene, hemispherical acetabular component with three (3) concentric grooves on the outer diameter and 3 circular indentations equally-spaced around the circumference near the middle of the cup. It is provided in eleven (11) sizes for the 28mm inner diameter, ranging from outer diameters of 40mm to 60mm.
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