THERMOFX MESH— 510(k) K003757

Substantially Equivalent

Bionx Implants, Ltd.

FDA 510(k) clearance K003757 for THERMOFX MESH, Substantially Equivalent on 2001-02-07. Applicant: Bionx Implants, Ltd..

Clearance details

Applicant: Bionx Implants, Ltd.
Product code: Code JEY
Advisory panel: Dental
Date received: 2000-12-06
Decision date: 2001-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

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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.