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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K200113
Device Name LINK TrabecuLink Tibial Cones
Applicant
Waldemar Link GmbH & Co. KG
Oststrabe 4-10
Norderstedt,  DE 22844
Applicant Contact Stefanie Fuchs
Correspondent
Waldemar Link GmbH & Co. KG
Oststrabe 4-10
Norderstedt,  DE 22844
Correspondent Contact Stefanie Fuchs
Regulation Number888.3565
Classification Product Code
MBH  
Date Received01/17/2020
Decision Date 03/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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