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510(k) Data Aggregation

    K Number
    K201147
    Device Name
    Elos® Intramedullary Nailing System
    Manufacturer
    Date Cleared
    2021-07-19

    (446 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Intrauma S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The short length Elos nails are intended for stabilizing various types of intertrochanteric fractures of the form. The long length Elos nails are intended for fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
    Device Description
    The Elos Intramedullary Nailing System consists of a titanium nail, cephalic screw, diaphyseal screw, optional closure cap, and a pre-assembled cannulated grub screw to lock cephalic screws. The short nails are available in lengths of 180mm and 10mm and 11mm in diameter. The short nails also have CCD angles of 122° and 127°. The 180mm short nail is available in one configuration for both left and right femurs and the 240mm nail is available in both left and right configurations. The long length nails are 11mm in diameter, in lengths of 300mm, 340mm, 380mm, 400mm, 420m, 440mm and 460 mm and are offered in left and right configurations. The long nails are also offered with CCD angles of 122° and 127°. The nails, screws, and closure cap undergo an anodic oxidation (Type II Anodization) treatment.
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