Neurosurgeon Gets 510(k) for Fusion Device

A spinal implant developed by a South Dakota neurosurgeon has received FDA 510(k) clearance as a lumbar intervertebral body fusion device, according to a statement from Sanford Clinic Neurosurgery and Spine. The Asfora Bullet Cage is used in posterior lumbar interbody fusion surgeries to treat degenerative disc disease. Wilson Asfora, the device’s developer, says it has demonstrated up to a 98 percent rate of interbody fusion of one or two levels in hundreds of cases using locally harvested bone without the use of pedicle screws and bone morphogenic protein.