Sonoma Fibula Repair System

Sonoma Fibula Repair System is an FDA 510(k)-cleared medical device (K160069) manufactured by Sonoma Orthopedics 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 March 9, 2016. Regulation: 8.