MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM— 510(k) K043297

Substantially Equivalent

Medicon EG

FDA 510(k) clearance K043297 for MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM, Substantially Equivalent on 2005-02-23. Applicant: Medicon EG.

Clearance details

Applicant: Medicon EG
Product code: Code JEY
Advisory panel: Dental
Date received: 2004-11-29
Decision date: 2005-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.