Pectus Versa System— 510(k) K251050

Name: FDA 510(k) clearance K251050
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Substantially Equivalent

Gm Dos Reis Industria E Comercio

FDA 510(k) clearance K251050 for Pectus Versa System, Substantially Equivalent on 2025-12-19. Applicant: Gm Dos Reis Industria E Comercio. Device class: 2.

Clearance details

Applicant: Gm Dos Reis Industria E Comercio
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-04-03
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21

More clearances from Gm Dos Reis Industria E Comercio

view all

K250559 — GMReis Fibula Nail System2025-06-12

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.