REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION

REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION is an FDA 510(k)-cleared medical device (K142135) manufactured by Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 27, 2014. Regulation: 8.