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510(k) Data Aggregation

    K Number
    K052483
    Device Name
    SYNTHES (USA) SPHERICAL WASHERS
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2005-11-04

    (56 days)

    Product Code
    NDG, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    NDG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments. In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
    Device Description
    The Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium.
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