VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION

VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION is an FDA 510(k)-cleared medical device (K133784) manufactured by Zimmer Trabecular Metal Technology. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 2014. Regulation: 8.