FLEXIBLE FASCICULATED BONE PLATE— 510(k) K870041

Substantially Equivalent

The Deca Co.

FDA 510(k) clearance K870041 for FLEXIBLE FASCICULATED BONE PLATE, Substantially Equivalent on 1987-07-17. Applicant: The Deca Co..

Clearance details

Applicant: The Deca Co.
Product code: Code JEY
Advisory panel: Dental
Date received: 1987-01-05
Decision date: 1987-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

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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.