BioArchitects Patient Specific Cranial/Craniofacial Plate— 510(k) K151692
Substantially EquivalentBioarchitects USA, LLC
FDA 510(k) clearance K151692 for BioArchitects Patient Specific Cranial/Craniofacial Plate, Substantially Equivalent on 2015-11-20. Applicant: Bioarchitects USA, LLC.
Clearance details
- Applicant
- Bioarchitects USA, LLC
- Product code
- Code GXN
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, 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.