510(k) K243907

Affixus Tibial Nailing System - 4mm screws by Zimmer, Inc. — Product Code HSB

K243907 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Affixus Tibial Nailing System - 4mm screws". The FDA issued a decision of Substantially Equivalent on February 12, 2025. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Zimmer, Inc. has at least 10 other 510(k) clearances on record.