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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K221794
Device Name Vario-Cup System
Applicant
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Applicant Contact Pia Mueller
Correspondent
LinkBio Corp.
69 King St.
Dover,  NJ  07801
Correspondent Contact Mateusz Leszczak
Regulation Number888.3390
Classification Product Code
KWY  
Date Received06/21/2022
Decision Date 07/20/2022
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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