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510(k) Data Aggregation
K Number
K162283Device Name
DCM Kyphoplasty System
Manufacturer
Date Cleared
2017-02-06
(175 days)
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
Dragon Crown Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DCM Kyphoplasty 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 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
The DCM Kyphoplasty System is designed to reduce compression fracture and create 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.
DCM Kyphoplasty System contains balloon catheter, balloon inflator, puncture needle and tool kit.
The balloon catheter is used to position inside of the vertebral body where it is inflated to make a cavity. The balloon inflator is used to inflate the balloon catheter that is filled with a contrast agent. The puncture needle is used to percutaneous puncture during the surgery and have two types: locking and rotating. The tool kit is used to support to perform the surgery and fill the bone cement. All parts of DCM Kyphoplasty System are supplied sterile and are single use only.
The balloon catheter has four specifications: Φ9×15, Φ12×19, Φ14×17 and Φ17×22. Balloon Inflator has two specifications: 20ml/30atm, 25ml/30atm. Puncture Needle has seven specifications: Φ2.5×100, Ф2.5×130, Ф3.0×100, Ф3.2×100, Ф3.2×130, Ф3.5×126, Ф4.0×126.
The tool kit is consisting of bone expander, spiral propeller, guide needle, expansion tube, working cannula, solid vertebral drill, hollow vertebral drill, push rod, bone cement injector and locator. They are supplied sterile and are single use only.
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