P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)

P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) is an FDA 510(k)-cleared medical device (K971189) manufactured by Johnson & Johnson Professionals, 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 July 16, 1997. Regulation: 8.