TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES

TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES is an FDA 510(k)-cleared medical device (K132632) manufactured by Tornier, 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 September 18, 2013. Regulation: 8.