Super Upper Limbs Versalock Plating System— 510(k) K260390

Name: FDA 510(k) clearance K260390
Creator: U.S. Food and Drug Administration
Published: 2026-03-17

Substantially Equivalent

GM Dos Reis Industria e Comercio Ltda.

FDA 510(k) clearance K260390 for Super Upper Limbs Versalock Plating System, Substantially Equivalent on 2026-03-17. Applicant: GM Dos Reis Industria e Comercio Ltda.. Device class: 2.

Clearance details

Applicant: GM Dos Reis Industria e Comercio Ltda.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-02-06
Decision date: 2026-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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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 Ltda.

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K253910 — Stitch - Suture Wires and Tapes2026-08-22
K254188 — Meniscus Versaflex2026-02-19
K252664 — GMReis Suture Anchors2025-11-04
K243905 — Stitch Cerclage Suture Tapes2025-08-14
K243740 — Versalock Upper Limb Plating System2025-01-29

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.