BIOMET MICROFIXATION NEURO PLATING SYSTEM— 510(k) K121624

Substantially Equivalent

Biomet Microfixation

FDA 510(k) clearance K121624 for BIOMET MICROFIXATION NEURO PLATING SYSTEM, Substantially Equivalent on 2012-10-12. Applicant: Biomet Microfixation.

Clearance details

Applicant: Biomet Microfixation
Product code: Code GWO
Advisory panel: Neurology
Date received: 2012-06-01
Decision date: 2012-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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.