K112812

Substantially Equivalent

LEFORTE NEURO SYSTEM BONE PLATE

Applicant: Jeil Medical Corporation
Product code: GWO
Advisory panel: Neurology
Date received: 2011-09-27
Decision date: 2012-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Norcross, GA, US

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.