Sonoma Fibula Repair System

Sonoma Fibula Repair System is an FDA 510(k)-cleared medical device (K142945) manufactured by Sonoma Orthopedic Products, 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 January 21, 2015. Regulation: 8.