EzFuze Implant System— 510(k) K150211

Substantially Equivalent

Vilex IN Tennessee, Inc.

FDA 510(k) clearance K150211 for EzFuze Implant System, Substantially Equivalent on 2015-11-10. Applicant: Vilex IN Tennessee, Inc..

Clearance details

Applicant: Vilex IN Tennessee, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2015-01-30
Decision date: 2015-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.