K143285

Substantially Equivalent

Mandible External Fixator - MR Conditional

Applicant: Synthes USA Products, LLC
Product code: MQN
Advisory panel: Dental
Date received: 2014-11-17
Decision date: 2015-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

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.