INVISIKNOT Ankle Syndesmosis Repair Kit

INVISIKNOT Ankle Syndesmosis Repair Kit is an FDA 510(k)-cleared medical device (K162996) 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 June 7, 2017. Regulation: 8.