HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)

HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) is an FDA 510(k)-cleared medical device (K130539) manufactured by Depuy Mitek, A Johnson & Johnson Company. 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 20, 2013. Regulation: 8.