SYNOVIS COLLAGEN MATRIX (TBD)

SYNOVIS COLLAGEN MATRIX (TBD) is an FDA 510(k)-cleared medical device (K122306) manufactured by Synovis Surgical Innovations. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 2013. Regulation: 8.