Super Upper Limbs Versalock Plating System— 510(k) K260390
Substantially EquivalentGM 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.
Summary
GM Dos Reis Industria e Comercio's Super Upper Limbs Versalock Plating System is filed under HRS, bone fixation plates. The record doesn't list the plates in the system.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
GM Dos Reis Industria e Comercio filed from Campinas, Brazil. Review took 39 calendar days (February 6 to March 17, 2026).
Clearance details
- Applicant
- GM Dos Reis Industria e Comercio Ltda.
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campinas, BR
Recent devices under product code HRS
view allMore clearances from GM Dos Reis Industria e Comercio Ltda.
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . 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.