EXPERT - Flexible Joint Fixation System— 510(k) K242311

Substantially Equivalent

GM Dos Reis Industria e Comercio Ltda.

FDA 510(k) clearance K242311 for EXPERT - Flexible Joint Fixation System, Substantially Equivalent on 2024-11-01. Applicant: GM Dos Reis Industria e Comercio Ltda..

Clearance details

Applicant: GM Dos Reis Industria e Comercio Ltda.
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2024-08-05
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.