BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM

BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM is an FDA 510(k)-cleared medical device (K970897) 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 20, 1997. Regulation: 8.