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Cayenne Medical, Inc.
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LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE is an FDA 510(k)-cleared medical device (K112960) manufactured by Cayenne Medical, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 8, 2012. Regulation: 8.