VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00— 510(k) K014154

Substantially Equivalent

Vilex, Inc.

FDA 510(k) clearance K014154 for VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00, Substantially Equivalent on 2002-03-18. Applicant: Vilex, Inc..

Clearance details

Applicant: Vilex, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2001-12-18
Decision date: 2002-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hills, PA, US

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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.