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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, Constrained, Cemented Or Uncemented, Metal/Polymer
510(k) Number K240639
Device Name PINNACLETM Constrained Acetabular Liners
Applicant
Depuy Ireland UC
Loughbeg Ringaskiddy
Ringaskiddy
Cork,  GB
Applicant Contact Jennifer Hill
Correspondent
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Correspondent Contact Jennifer Hill
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received03/06/2024
Decision Date 04/04/2024
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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