OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS

OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS is an FDA 510(k)-cleared medical device (K960647) 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 September 16, 1996. Regulation: 8.