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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K160907
Device Name DePuy Actis DuoFix Hip Prosthesis
Applicant
DEPUY (IRELAND)
LOUGHBEG RINGASKIDDY
Co. Cork,  IE
Applicant Contact Jaime Weeks
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46582
Correspondent Contact Correne Ramy
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWL   KWY   LPH  
Date Received04/01/2016
Decision Date 07/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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