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Mitek Worldwide
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BIOFASTIN RC THREADED SUTURE ANCHOR is an FDA 510(k)-cleared medical device (K021883) manufactured by Mitek Worldwide. 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 30, 2002. Regulation: 8.