5.5 MM SUTURE LOCK BONE SCREW ANCHOR

5.5 MM SUTURE LOCK BONE SCREW ANCHOR is an FDA 510(k)-cleared medical device (K080229) manufactured by Kfx Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 28, 2008. Regulation: 8.