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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K231526
Device Name CORAIL Cemented Femoral Stem
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy
Co. Cork,  IE
Applicant Contact Amy Joyce
Correspondent
Depuy Ireland UC
Loughbeg
Ringaskiddy
Co. Cork,  IE
Correspondent Contact Nicola Keedy
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Codes
KWL   LZO  
Date Received05/26/2023
Decision Date 12/19/2023
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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