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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K173960
Device Name DePuy Corail AMT Hip Prosthesis
Applicant
Depuy France S.A.S.
7 Allee Irene Joliot Curie Bp256
Saint Priest Cedex Rhone-Alpes,  FR 69801
Applicant Contact David Holzwarth
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Melissa Cook
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY   MEH  
Date Received12/28/2017
Decision Date 09/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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