Titanium TomoFix Medial High Tibia Plate Anatomical

Titanium TomoFix Medial High Tibia Plate Anatomical is an FDA 510(k)-cleared medical device (K180213) manufactured by Synthes (USA) Products, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2018. Regulation: 8.