PICASSO II MIS SPINAL SYSTEM

PICASSO II MIS SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K140219) 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 April 13, 2014. Regulation: 8.