ACUMED TOTALW RIST FUSION PLATING SYSTEM

ACUMED TOTALW RIST FUSION PLATING SYSTEM is an FDA 510(k)-cleared medical device (K131380) 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 June 9, 2013. Regulation: 8.