Sonoma Cancellous Bone Screw and Washer

Sonoma Cancellous Bone Screw and Washer is an FDA 510(k)-cleared medical device (K150376) 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 June 11, 2015. Regulation: 8.