MONDEAL HAND CONTOUR SYSTEM— 510(k) K071797

Substantially Equivalent

Mondeal Medical Systems GmbH

FDA 510(k) clearance K071797 for MONDEAL HAND CONTOUR SYSTEM, Substantially Equivalent on 2007-09-17. Applicant: Mondeal Medical Systems GmbH.

Clearance details

Applicant: Mondeal Medical Systems GmbH
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2007-07-02
Decision date: 2007-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.