LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5— 510(k) K161747

Substantially Equivalent

Aap Implantate AG

FDA 510(k) clearance K161747 for LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5, Substantially Equivalent on 2016-11-22. Applicant: Aap Implantate AG.

Clearance details

Applicant: Aap Implantate AG
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2016-06-24
Decision date: 2016-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

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.