EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM

EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM is an FDA 510(k)-cleared medical device (K962553) 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 August 27, 1996. Regulation: 8.