K180064
Substantially EquivalentOsteoFab Patient Specific Cranial Device
- Applicant
- Oxford Performance Materials, Inc.
- Product code
- GXN
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Windsor, CT, 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.