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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/Polymer, Porous Uncemented
510(k) Number K241636
Device Name MobileLink Acetabular Cup System - Line Extension (Multiple)
Applicant
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Applicant Contact Stefanie Fuchs
Correspondent
LinkBio Corp.
69 King St.
Dover,  NJ  07801
Correspondent Contact Luisa Moncada
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   MEH  
Date Received06/06/2024
Decision Date 11/08/2024
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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