LINK TrabecuLink Tibial Cones

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 Link Trabeculink Tibial Cones.

Pre-market Notification Details

Device IDK200113
510k NumberK200113
Device Name:LINK TrabecuLink Tibial Cones
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant Waldemar Link GmbH & Co. KG Oststrabe 4-10 Norderstedt,  DE 22844
ContactStefanie Fuchs
CorrespondentStefanie Fuchs
Waldemar Link GmbH & Co. KG Oststrabe 4-10 Norderstedt,  DE 22844
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-17
Decision Date2020-03-18

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