J-SERIES OMEGA TOTAL HIP SYSTEM

J-SERIES OMEGA TOTAL HIP SYSTEM is an FDA 510(k)-cleared medical device (K990003) 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 February 23, 1999. Regulation: 8.