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510(k) Data Aggregation
K Number
K232842Device Name
Balloon Inflation System
Manufacturer
Ningbo HicRen Biotechnology Co., Ltd.
Date Cleared
2024-02-29
(168 days)
Product Code
NDN
Regulation Number
888.3027Why 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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