VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24— 510(k) K991197

Substantially Equivalent

Vilex, Inc.

FDA 510(k) clearance K991197 for VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Substantially Equivalent on 1999-04-26. Applicant: Vilex, Inc..

Clearance details

Applicant: Vilex, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1999-04-07
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.