
Smith & Nephew Inc., Endoscopy Division
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TWINFIX FT PK is an FDA 510(k)-cleared medical device (K072785) manufactured by Smith & Nephew Inc., Endoscopy Division. 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 9, 2007. Regulation: 8.