P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL

P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL is an FDA 510(k)-cleared medical device (K910563) 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 May 22, 1991. Regulation: 8.