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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 K243927
Device Name MobileLink Acetabular Cup System - inhouse coatings
Applicant
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Applicant Contact Stefanie Fuchs
Correspondent
Linkbio Corp. (U.S. Distributor/Initial Importer)
69 King St.
Dover,  NJ  07801
Correspondent Contact Terry Powell
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received12/20/2024
Decision Date 05/16/2025
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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