Versalock Periprosthetic Femur Plates System-GMReis— 510(k) K201728

Substantially Equivalent

GM Dos Reis Industria e Comercio Ltda.

FDA 510(k) clearance K201728 for Versalock Periprosthetic Femur Plates System-GMReis, Substantially Equivalent on 2021-03-08. Applicant: GM Dos Reis Industria e Comercio Ltda..

Clearance details

Applicant: GM Dos Reis Industria e Comercio Ltda.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2020-06-23
Decision date: 2021-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.