VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX

VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX is an FDA 510(k)-cleared medical device (K111983) 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 November 17, 2011. Regulation: 8.