510(k) K262537

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

K262537 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "Versalock Sterile Plating System". The FDA issued a decision of Substantially Equivalent on August 19, 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.