The LINK® Endo-Model® Knee System

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

Waldemar Link GmbH & Co. KG

The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for The Link® Endo-model® Knee System.

Pre-market Notification Details

• Device ID: K143179
• 510k Number: K143179
• Device Name: The LINK® Endo-Model® Knee System
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: Waldemar Link GmbH & Co. KG Barkhausenweg 10 Hamburg, DE 22339
• Contact: Helmut D. Link
• Correspondent: Thomas Mehler; Waldemar Link GmbH & Co. KG Barkhausenweg 10 Hamburg, DE 22339
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-04
• Decision Date: 2015-01-30
• Summary: summary