SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System

SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System is an FDA 510(k)-cleared medical device (K180156) manufactured by Globus Medical, 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 March 6, 2018. Regulation: 8.