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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 K233233
Device Name EMPHASYS Femoral Stems
Applicant
DePuy Ireland UC
Loughbeg
Ringaskiddy
Co. Cork,  IE
Applicant Contact Sarah Matamisa
Correspondent
DePuy Ireland UC
Loughbeg
Ringaskiddy
Co. Cork,  IE
Correspondent Contact Sarah Matamisa
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY   MEH  
Date Received09/28/2023
Decision Date 10/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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