The FDA issued 510(k) clearance to Aurora Spine Corporation for its ZIP Minimally Invasive Interspinous Fusion System.
According to a company press release, the system is a minimally invasive spinal fixation device for spinal fusion developed as an alternative to the pedicle screw system. It features articulating bone anchors, a one-step locking mechanism with no set screw and a large graft space designed for biologic material. It is designed for stabilization during T1-S1 lumbar fusion procedures, specifically for the treatment of degenerative disc disease, spondylolisthesis, spinal tumors and trauma. The company currently has distribution agreements in place with more than 35 distributors for sale in the United States. Full Story »