510(k) K250559

GMReis Fibula Nail System by Gm Dos Reis Industria E Comercio — Product Code HSB

K250559 is an FDA 510(k) premarket notification submitted by Gm Dos Reis Industria E Comercio for the device "GMReis Fibula Nail System". The FDA issued a decision of Substantially Equivalent on Jun 12, 2025. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Gm Dos Reis Industria E Comercio has at least 1 other 510(k) clearance on record.