Stitch Cerclage Suture Tapes— 510(k) K243905

Substantially Equivalent

GM Dos Reis Industria e Comercio Ltda.

FDA 510(k) clearance K243905 for Stitch Cerclage Suture Tapes, Substantially Equivalent on 2025-08-14. Applicant: GM Dos Reis Industria e Comercio Ltda..

Clearance details

Applicant: GM Dos Reis Industria e Comercio Ltda.
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2024-12-19
Decision date: 2025-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.