Details
Device typeInflatable bone tamp: A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
FDA categoryCEMENT, BONE, VERTEBROPLASTY
Device ID00884450327937
Catalog numberOT-0224/A
Single useYes
MRI safetyLabeling does not contain MRI Safety Information
SizeSize-4 mL / 20 mm
SizeGauge-10G