OMNI-FIX, NAIL SYSTEM

OMNI-FIX, NAIL SYSTEM is an FDA 510(k)-cleared medical device (K990307) 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 March 31, 1999. Regulation: 8.