AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT

AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT is an FDA 510(k)-cleared medical device (K133376) manufactured by Tornier, 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 December 4, 2013. Regulation: 8.