510(k) K243740

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

K243740 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "Versalock Upper Limb Plating System". The FDA issued a decision of Substantially Equivalent on January 29, 2025. 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.