510(k) K231114

Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System by Zimmer Switzerland Manufacturing GmbH — Product Code HSB

K231114 is an FDA 510(k) premarket notification submitted by Zimmer Switzerland Manufacturing GmbH for the device "Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System". The FDA issued a decision of Substantially Equivalent on August 9, 2023. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Zimmer Switzerland Manufacturing GmbH has at least 3 other 510(k) clearances on record.