RMHS POROUS DISTAL SLEEVE

RMHS POROUS DISTAL SLEEVE is an FDA 510(k)-cleared medical device (K930108) manufactured by Smith & Nephew Richards, 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 September 20, 1993. Regulation: 8.