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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/Polymer, Cemented
510(k) Number K220216
Device Name C-Stem AMT LE Prosthesis
Applicant
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Applicant Contact Sarah Matamisa
Correspondent
DePuy Orthopaedics, Inc.
Depuy Ireland Uc
Loughbeg, Ringaskiddy, Co. Cork,  IE
Correspondent Contact Sarah Matamisa
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LZO  
Date Received01/26/2022
Decision Date 07/22/2022
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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