ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES is an FDA 510(k)-cleared medical device (K951673) manufactured by Acu Med, 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 July 5, 1995. Regulation: 8.