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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 K123991
Device Name DEPUY CORAIL AMT HIP PROSTHESIS
Applicant
Depuy France S.A.S.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact ALMA RELJA, RAC
Correspondent
Depuy France S.A.S.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact ALMA RELJA, RAC
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Codes
KWL   LZO  
Date Received12/26/2012
Decision Date 09/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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