GEMINI SL Total Knee System, Endo-Model Knee System, And Sled Knee System With LINK PorEx (TiNbN) Inhouse Coating

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 Gemini Sl Total Knee System, Endo-model Knee System, And Sled Knee System With Link Porex (tinbn) Inhouse Coating.

Pre-market Notification Details

Device IDK212742
510k NumberK212742
Device Name:GEMINI SL Total Knee System, Endo-Model Knee System, And Sled Knee System With LINK PorEx (TiNbN) Inhouse Coating
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt,  DE 22844
ContactLydia Ditter
CorrespondentTerry Sheridan Powell
LinkBio Corp. 69 King Street Dover,  NJ  07801
Product CodeJWH  
Subsequent Product CodeHSX
Subsequent Product CodeKRO
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-30
Decision Date2021-09-16

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