CONSTRUX Mini PEEK Spacer System

CONSTRUX Mini PEEK Spacer System is an FDA 510(k)-cleared medical device (K202949) manufactured by Orthofix, 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 October 28, 2020. Regulation: 8.