510(k) K201728

Versalock Periprosthetic Femur Plates System-GMReis by GM Dos Reis Industria e Comercio Ltda. — Product Code HRS

K201728 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "Versalock Periprosthetic Femur Plates System-GMReis". The FDA issued a decision of Substantially Equivalent on March 8, 2021. 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.