APTUS® Foot 2.8-3.5 System— 510(k) K193639

Substantially Equivalent

Medartis AG

FDA 510(k) clearance K193639 for APTUS® Foot 2.8-3.5 System, Substantially Equivalent on 2020-03-26. Applicant: Medartis AG.

Clearance details

Applicant: Medartis AG
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2019-12-27
Decision date: 2020-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel-Stadt, CH

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.