DORSAL NAIL PLATE, ANATOMICAL— 510(k) K052248

Substantially Equivalent

Hand Innovations, LLC

FDA 510(k) clearance K052248 for DORSAL NAIL PLATE, ANATOMICAL, Substantially Equivalent on 2005-09-14. Applicant: Hand Innovations, LLC.

Clearance details

Applicant: Hand Innovations, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2005-08-18
Decision date: 2005-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

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.