
Depuy Mitek, A Johnson & Johnson Company
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GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. is an FDA 510(k)-cleared medical device (K111631) 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 July 21, 2011. Regulation: 8.