GENESIS CONSTRAINED SYSTEM (GCS)

GENESIS CONSTRAINED SYSTEM (GCS) is an FDA 510(k)-cleared medical device (K952271) 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 7, 1995. Regulation: 8.