SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION

SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION is an FDA 510(k)-cleared medical device (K132365) manufactured by Accel Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 2013. Regulation: 8.