Device typeVertebral body cement cannula: A sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty. It is typically inserted under fluoroscopic guidance to treat a patient diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine. The device is typically made of stainless steel with an attached plastic handle and available in a kit of several equal size cannulae (e.g., 3 or 6) to provide access to one or more sites of intervention. This is a single-use device.
FDA categoryInjector, Vertebroplasty (Does Not Contain Cement)
Device ID08033860034818
Catalog numberRESFIL1112C1-US
AvailabilityPrescription
Single useYes
SterileYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information
Needle Gauge10 Gauge
Length187 Millimeter