TenoTac Soft Tissue Fixation System

TenoTac Soft Tissue Fixation System is an FDA 510(k)-cleared medical device (K203385) manufactured by Paragon 28, 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 February 10, 2021. Regulation: 8.