CuffLink Implant System Biocomposite

CuffLink Implant System Biocomposite is an FDA 510(k)-cleared medical device (K180763) manufactured by Conmed Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 18, 2018. Regulation: 8.