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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 K190535
Device Name BiMobile Dual Mobility System - E-Dur Inserts
Applicant
Waldemar Link GmbH & Co. KG
Oststrasse 4-10
Norderstedt,  DE 22844
Applicant Contact Stefanie Fuchs
Correspondent
Waldemar Link GmbH & Co. KG
Oststrasse 4-10
Norderstedt,  DE 22844
Correspondent Contact Stefanie Fuchs
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received03/04/2019
Decision Date 08/06/2019
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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