BTI HUMERAL INTRAMEDULLARY ROD SYSTEM

BTI HUMERAL INTRAMEDULLARY ROD SYSTEM is an FDA 510(k)-cleared medical device (K980102) manufactured by Biodynamic Technologies, 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 April 2, 1998. Regulation: 8.