Parcus Twist AP Suture Anchors

Parcus Twist AP Suture Anchors is an FDA 510(k)-cleared medical device (K183501) 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 March 14, 2019. Regulation: 8.