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510(k) Data Aggregation
K Number
K113742Device Name
KMC KYPHOPLASTY SYSTEM
Manufacturer
Date Cleared
2012-09-17
(272 days)
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI KINETIC MEDICAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KMC Kyphoplasty System is 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. 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
KMC Kyphoplasty System consists of five components:
- Balloon Catheter .
- Tool Kit
- . Puncture Needle
- Balloon Catheter Syringe Pump .
- Kyphoplasty Multifunctional Tool .
The Kyphoplasty Multifunctional Tool can be substituted for the Puncture Needle and Kyphoplasty Tool Kit.
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