VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW— 510(k) K991151

Substantially Equivalent

Vilex, Inc.

FDA 510(k) clearance K991151 for VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW, Substantially Equivalent on 1999-04-26. Applicant: Vilex, Inc..

Clearance details

Applicant: Vilex, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1999-04-06
Decision date: 1999-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jefferson 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.