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510(k) Data Aggregation

    K Number
    K172214
    Device Name
    Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
    Manufacturer
    Date Cleared
    2017-08-23

    (30 days)

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

    G-21 s.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
    Device Description
    The inflation of the balloon serves to create a cavity in the vertebral body, compressing the cancellous bone and/or move cortical bone, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. Modified Winch Kypholplasy (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyhoplasty procedure. The low pre-inflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas. The stiff distal end of the balloon catheter provides rigidity for smooth insertion while the flexible proximal catheter allows for easy maneuverability. The inflating component, laserbonded to the shaft, is a low-pressure elastomeric balloon of tubular shape (which is inflated by volume, not pressure). The inflation can expand the balloon several times its original size, it can be inflated to precise dimensions and retain well defined shapes and high pressures and when the pressure is released, it recovers close to its original size and shape, re-folding back to similar original profiles.
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