510(k) K251050— Pectus Versa System

Substantially Equivalent

Gm Dos Reis Industria E Comercio

Clearance details

Applicant: Gm Dos Reis Industria E Comercio
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2025-04-03
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

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.