Tarsa-Link Stand-Alone Wedge Fixation System

Tarsa-Link Stand-Alone Wedge Fixation System is an FDA 510(k)-cleared medical device (K161037) manufactured by Life Spine, 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 14, 2016. Regulation: 8.