Pectus Blu Support Bar System

Pectus Blu Support Bar System is an FDA 510(k)-cleared medical device (K241709) manufactured by Biomet Microfixation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 18, 2024. Regulation: 8.