Affixus Tibial Nailing System - 4mm screws

Affixus Tibial Nailing System - 4mm screws is an FDA 510(k)-cleared medical device (K243907) manufactured by Zimmer, 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 February 11, 2025. Regulation: 8.