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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K122442
Device Name DEPUY CTA REVERSE SHOULDER SYSTEM
Applicant
Depuy France
700 Orthopaedic Dr.
Warsaw,  IN  46580
Applicant Contact MEGAN BURNS
Correspondent
Depuy France
700 Orthopaedic Dr.
Warsaw,  IN  46580
Correspondent Contact MEGAN BURNS
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received08/10/2012
Decision Date 09/06/2012
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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