510(k) K152431— LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating

Substantially Equivalent

Waldemar Link GmbH & Co. KG

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2015-08-26
Decision date: 2016-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

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.