Shadow Knotless All-Suture Anchors

Shadow Knotless All-Suture Anchors is an FDA 510(k)-cleared medical device (K233258) manufactured by Responsive Arthroscopy, 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 October 22, 2023. Regulation: 8.