Mandible External Fixator - MR Conditional— 510(k) K143285
Substantially EquivalentSynthes USA Products, LLC
FDA 510(k) clearance K143285 for Mandible External Fixator - MR Conditional, Substantially Equivalent on 2015-05-28. Applicant: Synthes USA Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes USA Products, LLC
- Product code
- Code MQN
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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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.