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510(k) Data Aggregation

    K Number
    K051820
    Device Name
    PARALLAX EZFLOW CEMENT DELIVERY SYSTEM
    Manufacturer
    ARTHROCARE CORP.
    Date Cleared
    2005-09-06

    (63 days)

    Product Code
    OAR
    Regulation Number
    888.4200
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    Product Code :

    OAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
    Device Description
    Parallax® EZFlow™ Cement Delivery System is a delivery system for the Parallax Acrylic Resin with TRACERS and Parallax Acrylic Resin with TRACERS Ta. It is designed to provide surgeons with a means to inject Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The EZFlow Cement Delivery System does not contain any bone cement material, as this system only consists of general instruments. All of the system components are manual, single-use disposable instruments.
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