Release Laminoplasty Fixation System

Release Laminoplasty Fixation System is an FDA 510(k)-cleared medical device (K153735) manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 2016. Regulation: 8.