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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
DePuy France S.A.S.
7 Allee Irene Joliot Curie Bp256
Saint Priest Cedex Rhone-Alpes,  FR 69801
Applicant Contact David Holzwarth
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Melissa Cook
Regulation Number888.3353
Classification Product Code
Subsequent Product Codes
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