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510(k) Data Aggregation

    K Number
    K232842
    Device Name
    Balloon Inflation System
    Manufacturer
    Ningbo HicRen Biotechnology Co., Ltd.
    Date Cleared
    2024-02-29

    (168 days)

    Product Code
    NDN
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo HicRen Biotechnology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Balloon Inflation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
    Device Description
    Balloon Inflation System is mainly used to treat vertebral compression fractures caused by osteoporosis. Puncture needles or dilators are used to establish working channels, then balloon catheters are placed along the working channels and inflation device connect to balloon catheter and control it expansion to lift the upper and lower endplates of the vertebral body, restore the height of the vertebral body, and form bone cement filling cavities.
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