Pectus Blu Support Bar System

Pectus Blu Support Bar System is an FDA 510(k)-cleared medical device (K212841) manufactured by Biomet Micofixation. 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 6, 2022. Regulation: 8.