The Aesculap Implant Systems A-Fix Spinal System received 510(k) clearance under K100802 by the U.S. Food and Drug Administration (FDA) on July 20, 2010.
The A-Fix Spinal System is a stand-alone interbody fusion device developed for the anterior surgical approach and is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease with up to Grade 1 spondylolisthesis at the involved level(s).