Biomet Microfixation OmniMax MMF System— 510(k) K152326

Substantially Equivalent

Biomet Microfixation

FDA 510(k) clearance K152326 for Biomet Microfixation OmniMax MMF System, Substantially Equivalent on 2015-12-10. Applicant: Biomet Microfixation.

Clearance details

Applicant: Biomet Microfixation
Product code: Code JEY
Advisory panel: Dental
Date received: 2015-08-18
Decision date: 2015-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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.