BIOSORBFX O/M 2.0/2/4 SYSTEM— 510(k) K011569

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K011569 for BIOSORBFX O/M 2.0/2/4 SYSTEM, Substantially Equivalent on 2002-02-22. Applicant: Bionx Implants, Inc..

Clearance details

Applicant: Bionx Implants, Inc.
Product code: Code JEY
Advisory panel: Dental
Date received: 2001-05-21
Decision date: 2002-02-22
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.