510(k) K261406

Versalock Proximal Tibial Plating System by GM Dos Reis Industria e Comercio Ltda. — Product Code HRS

K261406 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "Versalock Proximal Tibial Plating System". The FDA issued a decision of Substantially Equivalent on July 21, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. GM Dos Reis Industria e Comercio Ltda. has at least 10 other 510(k) clearances on record.