INION CPS ORBITAL PLATES— 510(k) K122890

Substantially Equivalent

Inion OY

FDA 510(k) clearance K122890 for INION CPS ORBITAL PLATES, Substantially Equivalent on 2013-01-29. Applicant: Inion OY.

Clearance details

Applicant: Inion OY
Product code: Code JEY
Advisory panel: Dental
Date received: 2012-09-20
Decision date: 2013-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

Download summary PDF View 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, 2020-01-01 through 2026-04-23. 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.