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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 K182321
Device Name MobileLink Acetabular Cup System
Applicant
Waldemar Link GmbH & Co. KG
Oststrabe 4-1 0
Norderstedt,  DE 22844
Applicant Contact Karen Sonnenberger
Correspondent
Waldemar Link GmbH & Co. KG
Oststrabe 4-1 0
Norderstedt,  DE 22844
Correspondent Contact Karen Sonnenberger
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LPH   MEH   OQG  
Date Received08/27/2018
Decision Date 05/24/2019
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
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