CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE is an FDA 510(k)-cleared medical device (K120903) manufactured by Acumed, LLC. 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 12, 2012. Regulation: 8.