KONG-TL VBR System, KONG-C VBR System— 510(k) K200235

Substantially Equivalent

Icotec AG

FDA 510(k) clearance K200235 for KONG-TL VBR System, KONG-C VBR System, Substantially Equivalent on 2020-05-29. Applicant: Icotec AG.

Clearance details

Applicant: Icotec AG
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2020-01-30
Decision date: 2020-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altstaetten, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.