510(k) K253116— 3D MAC Titanium Cranial Plate (TCP) System
Substantially EquivalentThe Surgeon General, Department of the Army (TSG-DA)
Clearance details
- Applicant
- The Surgeon General, Department of the Army (TSG-DA)
- Product code
- Code GXN
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Detrick, MD, 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.