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510(k) Data Aggregation

    K Number
    K070293
    Device Name
    BENVENUE VCF OSTEO COIL SYSTEM
    Manufacturer
    BENVENUE MEDICAL, INC.
    Date Cleared
    2007-07-10

    (160 days)

    Product Code
    OCJ
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    OCJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Benvenue VCF Osteo Coil System is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).
    Device Description
    The Benvenue VCF Osteo Coil System is packaged as a single-use, sterile, non-implantable device. It is a surgical instrument designed to be used in percutaneous applications, for the creation of channels within the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA). The Benvenue VCF Osteo Coil System consists of three primary components: Nitinol Osteo Coil, Deployment Cannula with PEEK liner, and Handle. The nitinol Osteo Coil is pre-set into a loop shape and can be temporarily straightened into a cannula for deployment into cancellous bone. Once positioned in the cancellous bone, the Osteo Coil is advanced forward out of the cannula. The surgeon controls the amount of Osteo Coil deployment with the use of the handle, which allows for incremental deployment and directional control. Upon exiting the Osteo coil regains its loop shape as it channels through the cancellous bone. The device is available in two sizes. This system does not include the bone cement.
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