Craniomaxillofacial Distraction System (CMFD)— 510(k) K162594
Substantially EquivalentSynthes USA Products, LLC
FDA 510(k) clearance K162594 for Craniomaxillofacial Distraction System (CMFD), Substantially Equivalent on 2017-05-08. Applicant: Synthes USA Products, LLC.
Clearance details
- Applicant
- Synthes USA Products, LLC
- Product code
- Code MQN
- Advisory panel
- Dental
- Date received
- Decision date
- 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, 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.