SYNTHES LCP PEDIATRIC PLATE SYSTEMS

SYNTHES LCP PEDIATRIC PLATE SYSTEMS is an FDA 510(k)-cleared medical device (K112085) manufactured by Synthes (USA) Products, 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 November 16, 2011. Regulation: 8.