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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 K213839
Device Name DePuy Corail AMT Hip Prosthesis
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Applicant Contact Erin Combs
Correspondent
Depuy(Ireland)
Loughbeg Ringaskiddy
Cork,  IE P43ED82
Correspondent Contact Paul Shin
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY   MEH  
Date Received12/09/2021
Decision Date 01/06/2022
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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