
Depuy Mitek, A Johnson & Johnson Company
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MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR is an FDA 510(k)-cleared medical device (K070925) 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 1, 2007. Regulation: 8.