X-Twist PEEK Suture Anchor

X-Twist PEEK Suture Anchor is an FDA 510(k)-cleared medical device (K221135) manufactured by Parcus Medical, LLC. 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 18, 2022. Regulation: 8.