Grappler Suture Anchor R3FLEX IOL System

Grappler Suture Anchor R3FLEX IOL System is an FDA 510(k)-cleared medical device (K223589) manufactured by Paragon 28, 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 March 2, 2023. Regulation: 8.