MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS— 510(k) K073556

Name: FDA 510(k) clearance K073556
Creator: U.S. Food and Drug Administration
Published: 2008-06-24

Substantially Equivalent

Medxpert GmbH

FDA 510(k) clearance K073556 for MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS, Substantially Equivalent on 2008-06-24. Applicant: Medxpert GmbH. Device class: 2.

Clearance details

Applicant: Medxpert GmbH
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2007-12-19
Decision date: 2008-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mühlheim An Der Donau, DE

Download summary PDF View on FDA.gov ↗

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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.