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    K Number
    K063606
    Device Name
    MODIFICATION TO STAXX FX SYSTEM
    Manufacturer
    SPINE WAVE, INC.
    Date Cleared
    2007-04-13

    (133 days)

    Product Code
    OBL
    Regulation Number
    888.3027
    Why did this record match?
    Product Code :

    OBL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.
    Device Description
    The StaXx™ FX System is a vertebral fracture reduction device composed of a base wafer and stackable wafers fabricated from preformed Polyetheretherketone (PEEK-OPTIMA) with 6% Barium Sulfate (BaSO4). The wafers are designed to be inserted incrementally into the vertebral body to form a column that provides the desired fracture reduction. Twenty (20) wafers are provided per package. The wafers are provided in one width (8mm) with three lengths (20mm, 25mm, 30mm).
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