LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, And Shell/Insert Adapters

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

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 Mobilelink® Acetabular Cup System - Dual Mobility Liners, And Shell/insert Adapters.

Pre-market Notification Details

Device IDK200607
510k NumberK200607
Device Name:LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, And Shell/Insert Adapters
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Waldemar Link GmbH & Co. KG Ostsraße 4-10 Norderstedt,  DE 22844
ContactStafanie Fuchs
CorrespondentStefanie Fuchs
Waldemar Link GmbH & Co. KG Ostsraße 4-10 Norderstedt,  DE 22844
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2021-05-28

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