OMNI-FIX, HUMERAL NAIL

OMNI-FIX, HUMERAL NAIL is an FDA 510(k)-cleared medical device (K991405) manufactured by Turnkey Intergration USA, 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 June 28, 1999. Regulation: 8.