ORTHOFIX VOLAR DISTAL RADIAL PLATE— 510(k) K042766

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K042766 for ORTHOFIX VOLAR DISTAL RADIAL PLATE, Substantially Equivalent on 2004-11-16. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2004-10-05
Decision date: 2004-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mckinney, TX, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.