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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 K192559
Device Name Acetabular Bone Screws (for MobileLink Acetabular Cup System)
Applicant
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Applicant Contact Karen Sonnenberger
Correspondent
LinkBio Corp.
69 King St.
Dover,  NJ  07801
Correspondent Contact Terry Powell
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LPH   MEH   OQG  
Date Received09/17/2019
Decision Date 12/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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