TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD

TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD is an FDA 510(k)-cleared medical device (K111337) manufactured by Tornier, 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 January 24, 2012. Regulation: 8.