IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS

IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS is an FDA 510(k)-cleared medical device (K934590) 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 June 13, 1995. Regulation: 8.