LOW PROFILE SLEAVE NUT ASSEMBLY

LOW PROFILE SLEAVE NUT ASSEMBLY is an FDA 510(k)-cleared medical device (K931208) manufactured by Advanced Spine Fixation Systems, 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 March 27, 1994. Regulation: 8.