P.F.C. BIPOLAR HIP SYSTEM

P.F.C. BIPOLAR HIP SYSTEM is an FDA 510(k)-cleared medical device (K931655) manufactured by Johnson & Johnson Orthopaedics, 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 June 8, 1994. Regulation: 8.