VISIONAIRE UK Patient Matched Cutting Guides

VISIONAIRE UK Patient Matched Cutting Guides is an FDA 510(k)-cleared medical device (K211512) 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 September 15, 2021. Regulation: 8.