HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)

HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) is an FDA 510(k)-cleared medical device (K131683) manufactured by Depuy Mitek, Inc., A Johnson and 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 June 26, 2013. Regulation: 8.