OMEGA II MODULAR TOTAL HIP SYSTEM

OMEGA II MODULAR TOTAL HIP SYSTEM is an FDA 510(k)-cleared medical device (K984227) 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 April 7, 1999. Regulation: 8.