OMEGA HA COATED TOTAL HIP SYSTEM

OMEGA HA COATED TOTAL HIP SYSTEM is an FDA 510(k)-cleared medical device (K980981) manufactured by Osteoimplant Technology, 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 May 19, 1998. Regulation: 8.