TRUE/FLEX INTRAMEDULLARY ROD END-CAP

TRUE/FLEX INTRAMEDULLARY ROD END-CAP is an FDA 510(k)-cleared medical device (K944501) manufactured by Applied Osteo Systems, 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 November 27, 1994. Regulation: 8.