P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY

P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY is an FDA 510(k)-cleared medical device (K991106) manufactured by DePuy 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, 1999. Regulation: 8.