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510(k) Data Aggregation

    K Number
    K051017
    Device Name
    R-X-FIX EXTERNAL FIXATOR
    Manufacturer
    R-X-FIX
    Date Cleared
    2005-06-29

    (69 days)

    Product Code
    KTT
    Regulation Number
    888.3030
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    Applicant Name (Manufacturer) :

    R-X-FIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R-X-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies.
    Device Description
    The R-X-Fix External Fixator is a stable solution for fractures and for lengthening of small bones. The R-X-Fix External Fixator is hinged to allow adjustment in horizontal or vertical axis and is used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The hinge system allows range of motion at the joint during treatment. The design allows the placement of pins to be adjusted around three orthogonal axes and translated linearly.
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