OPTI-FIX TOTAL HIP SYSTEM

OPTI-FIX TOTAL HIP SYSTEM is an FDA 510(k)-cleared medical device (K860635) manufactured by Richards Medical Co., 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 13, 1986. Regulation: 8.