SPIRA-C Integrated Fixation System

SPIRA-C Integrated Fixation System is an FDA 510(k)-cleared medical device (K193153) manufactured by Camber Spine Technologies. 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 23, 2020. Regulation: 8.