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510(k) Data Aggregation

    K Number
    K954856
    Device Name
    CANNULATED FEMORAL NAIL
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1996-03-08

    (137 days)

    Product Code
    JDN
    Regulation Number
    888.3060
    Why did this record match?
    Product Code :

    JDN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthes CFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures.
    Device Description
    Synthes CFN is a cannulated locking intramedullary fixation device. It is cannulated throughout the length of the nail which facilitates insection over a guide rod into a reamed or unreamed femur. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The most proximal locking hole is elongated. Nail accessories include a Twisted Blade, 5.0 mm Shaft Screws, Locking Sleeves, 4.9 mm Locking Bolts, and End Caps. The accessories are intended to transmit load between the bone and the CFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures. The device is manufactured from titanium alloy.
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