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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 K202472
Device Name ACTIS Duofix Hip Prosthesis
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.,
Warsaw,  IN  46582
Applicant Contact Karen Mahoney
Correspondent
Depuy Ireland
Loughbeg Ringaskiddy
Cork,  IE P43ED82
Correspondent Contact Ann Geraghty
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWL   KWY   MEH  
Date Received08/28/2020
Decision Date 10/21/2020
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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