CONSTRUX MINI PEEK TI SPACER SYSTEM

CONSTRUX MINI PEEK TI SPACER SYSTEM is an FDA 510(k)-cleared medical device (K121649) manufactured by Orthofix. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2012. Regulation: 8.