DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM— 510(k) K002775

Substantially Equivalent

Hand Innovations, Inc.

FDA 510(k) clearance K002775 for DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM, Substantially Equivalent on 2000-12-05. Applicant: Hand Innovations, Inc..

Clearance details

Applicant: Hand Innovations, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2000-09-06
Decision date: 2000-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.