FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING— 510(k) K132600

Substantially Equivalent

Biomet Microfixation

FDA 510(k) clearance K132600 for FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING, Substantially Equivalent on 2013-10-02. Applicant: Biomet Microfixation.

Clearance details

Applicant: Biomet Microfixation
Product code: Code JEY
Advisory panel: Dental
Date received: 2013-08-20
Decision date: 2013-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Jacksonville, FL, 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.