DeviceClearance

K151692

Substantially Equivalent

BioArchitects Patient Specific Cranial/Craniofacial Plate

Applicant
Bioarchitects USA, LLC
Product code
GXN
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
Download summary PDF View on FDA.gov ↗

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.