SYNFIX-LR SPACER

SYNFIX-LR SPACER is an FDA 510(k)-cleared medical device (K072253) manufactured by Synthes Spine Co.Lp. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 2007. Regulation: 8.