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510(k) Data Aggregation

    K Number
    K122208
    Device Name
    EXTERNAL FIXATOR SYSTEM
    Date Cleared
    2012-12-20

    (148 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHRISTOPHER D. ENDARA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The external fixation system is a device intended to be used in treatment of bone conditions including limb lengthening, osteotomies, the arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
    Device Description
    The external fixation system includes various size components to accommodate various anatomies and injuries. The clamps enable the frame to be coupled to bone by securing the rods and Schanz Screws for the intended use. Components designed for this system are the medium clamp to accept the 8.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length and 5.0mm diameter x 150mm to 200mm lengths), and the large clamp to accept the 11.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length, 5.0mm diameter x 150mm length to 200mm lengths, and 6.0mm diameter x 225mm to 300mm lengths).
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