510(k) K253749

Affixus® Natural Nail® Proximal Humeral System by Zimmer Switzerland Manufacturing GmbH — Product Code HSB

K253749 is an FDA 510(k) premarket notification submitted by Zimmer Switzerland Manufacturing GmbH for the device "Affixus® Natural Nail® Proximal Humeral System". The FDA issued a decision of Substantially Equivalent on December 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 Switzerland Manufacturing GmbH has at least 3 other 510(k) clearances on record.