Stryker Facial iD System— 510(k) K232350

Substantially Equivalent

Stryker Craniomaxillofacial

FDA 510(k) clearance K232350 for Stryker Facial iD System, Substantially Equivalent on 2024-01-13. Applicant: Stryker Craniomaxillofacial.

Clearance details

Applicant
Stryker Craniomaxillofacial
Product code
Code JEY
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Portage, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JEY

product code JEY
Injury
1,542
Malfunction
2,292
Total
3,834

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.