LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE

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 Link Endo-model Knee System, Femoral Segments (augments), Uhmwpe.

Pre-market Notification Details

Device IDK211768
510k NumberK211768
Device Name:LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt,  DE 22844
ContactStefanie Fuchs
CorrespondentTerry Sheridan Powell
LinkBio Corp. 69 King Street Dover,  NJ  07801
Product CodeKRO  
Subsequent Product CodeJDI
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-08
Decision Date2021-06-30

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