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Foundry Newcoxi, Inc.
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CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 is an FDA 510(k)-cleared medical device (K122954) manufactured by Foundry Newcoxi, 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 December 18, 2012. Regulation: 8.