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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 K150862
Device Name DePuy Actis Duofox Hip Prosthesis
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46582
Applicant Contact CORRENE RAMY
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 Received04/01/2015
Decision Date 09/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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