The LINK® Endo-Model® Knee System— 510(k) K143179

Substantially Equivalent

Waldemar Link GmbH & Co. KG

FDA 510(k) clearance K143179 for The LINK® Endo-Model® Knee System, Substantially Equivalent on 2015-01-30. Applicant: Waldemar Link GmbH & Co. KG.

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2014-11-04
Decision date: 2015-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.