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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 K192919
Device Name Pinnacle Duofix HA Acetabular Cup Prosthesis
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Applicant Contact Kathy Harris
Correspondent
Depuy(Ireland)
Loughbeg, Ringakiddy
Cork,  IE P43D82
Correspondent Contact Margaret Shaughnessy
Regulation Number888.3358
Classification Product Code
LPH  
Date Received10/15/2019
Decision Date 11/26/2019
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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