Akros FibuLink™ Syndesmosis Repair Kit

Akros FibuLink™ Syndesmosis Repair Kit is an FDA 510(k)-cleared medical device (K173550) manufactured by Akros Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2017. Regulation: 8.