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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer cemented
510(k) Number K122442
Device Name DEPUY CTA REVERSE SHOULDER SYSTEM
Original Applicant
DEPUY FRANCE
700 orthopaedic drive
warsaw,  IN  46580
Original Contact megan burns
Regulation Number888.3660
Classification Product Code
KWS  
Date Received08/10/2012
Decision Date 09/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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