Arthrex BioSync® Bone Wedge

Arthrex BioSync® Bone Wedge is an FDA 510(k)-cleared medical device (K151256) manufactured by Arthex, 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 August 11, 2015. Regulation: 8.