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    K Number
    K223709
    Device Name
    Kyphoplasty Balloon Catheter
    Manufacturer
    Jiangsu Changmei Medtech Co., Ltd.
    Date Cleared
    2023-08-16

    (247 days)

    Product Code
    HRX, HXG
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Changmei Medtech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kyphoplasty Balloon Catheter is intended to be used for the reduction of fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).
    Device Description
    Kyphoplasty Balloon Catheter is an inflatable balloon catheter used in percutaneous kyphoplasty (PKP). The Balloon Catheter consists of an outer tube and core tube/rod, inflatable balloon located at the distal tip. The radiopaque markers located at the balloon tip to reflect the balloon position during positioning. The balloon catheter is supplied sterilized, single-use.
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