LINK® BiMobile(TM) Dual Mobility System

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

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 Link® Bimobile(tm) Dual Mobility System.

Pre-market Notification Details

• Device ID: K171273
• 510k Number: K171273
• Device Name: LINK® BiMobile(TM) Dual Mobility System
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: Waldemar Link Gmbh & Co. KG Barkhausenweg 10 Hamburg, DE 22339
• Contact: Stefanie Reimers
• Correspondent: Henrik Kroh; Waldemar Link Gmbh & Co. KG Barkhausenweg 10 Hamburg, DE 22339
• Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-01
• Decision Date: 2018-01-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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