Smith & Nephew VISIONAIRE Adaptive Guides

Smith & Nephew VISIONAIRE Adaptive Guides is an FDA 510(k)-cleared medical device (K170282) 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 21, 2017. Regulation: 8.