Versalock Sterile Plating System— 510(k) K262537
Substantially EquivalentGM Dos Reis Industria e Comercio Ltda.
FDA 510(k) clearance K262537 for Versalock Sterile Plating System, Substantially Equivalent on 2026-08-19. Applicant: GM Dos Reis Industria e Comercio Ltda.. Device class: 2.
Summary
GM Dos Reis Industria e Comercio filed the Versalock Sterile Plating System under product code HRS, bone fixation plates. The record gives no model numbers.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).
The applicant filed from Campinas, Brazil. The decision came 27 calendar days after receipt (July 23 to August 19, 2026), and it was substantially equivalent.
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
- Special
- 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.