DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional— 510(k) K192702
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K192702 for DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional, Substantially Equivalent on 2020-09-18. Applicant: Synthes (USA) Products, LLC.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code GXN
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Adverse events under product code GXN
product code GXN- Injury
- 208
- Total
- 208
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.