K143338

Substantially Equivalent

Argulated Locking Plates

Applicant: Osteomed LP
Product code: JEY
Advisory panel: Dental
Date received: 2014-11-20
Decision date: 2015-04-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Addison, TX, US

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.