Akros Fibulink Syndesmosis Repair Kit

Akros Fibulink Syndesmosis Repair Kit is an FDA 510(k)-cleared medical device (K162805) 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 January 9, 2017. Regulation: 8.