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510(k) Data Aggregation

    K Number
    K942032
    Device Name
    PLAMP, PLAMP PLATE, PLAMP WITH HOOK
    Date Cleared
    1996-06-13

    (779 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOSPITAL FOR SPECIAL SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to fix periprosthetic fractures of the proximal femur and the humerus in a stable position to allow healing. The plamp plate with trochanteric hook is intended to fix nonunions of the trochanter in a stable position to allow healing.
    Device Description
    The plamp is a mechanical combination of a bone plate and a bone clamp. The clamps connect to the plate via the screws and the bone is held between the plate and the clamps. Both the plate and the clamps have small spikes to fix the components to the bone. For periprosthetic fractures, additional fixation is achieved through the use of cortical bone screws that pass through the plamp plate.
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