LinkSymphoKnee System

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 Linksymphoknee System.

Pre-market Notification Details

Device IDK202924
510k NumberK202924
Device Name:LinkSymphoKnee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Waldemar Link GmbH & Co. KG Oststrasse 4-10 Norderstedt,  DE 22844
ContactStefanie Fuchs
CorrespondentTerry Powell
LinkBio Corp. 69 King Street Dover,  NJ  07801
Product CodeJWH  
Subsequent Product CodeHRY
Subsequent Product CodeHSX
Subsequent Product CodeKRO
Subsequent Product CodeOIY
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-05-13

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