
Smith & Nephew, Inc.
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TFCC FAST-FIX KIT is an FDA 510(k)-cleared medical device (K132079) manufactured by Smith & Nephew, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2013. Regulation: 8.