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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K183141
Device Name LINK MP Monoblock Hip Prosthesis
Applicant
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Applicant Contact Andre von Malotki
Correspondent
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Correspondent Contact Andre von Malotki
Regulation Number888.3353
Classification Product Code
LZO  
Date Received11/13/2018
Decision Date 02/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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