Flex-ThreadTM Distal Fibula Intramedullary Nail System

Flex-ThreadTM Distal Fibula Intramedullary Nail System is an FDA 510(k)-cleared medical device (K202858) manufactured by Conventus Orthopaedics, LLC. 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 21, 2021. Regulation: 8.