JOURNEY II BCS CONSTRAINED INSERTS

JOURNEY II BCS CONSTRAINED INSERTS is an FDA 510(k)-cleared medical device (K140555) manufactured by Smith & Nephew, 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 May 28, 2014. Regulation: 8.