FDA 510(k) Application Details - K122442

Device Classification Name

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510(K) Number K122442
Device Name DEPUY CTA REVERSE SHOULDER SYSTEM
Applicant DEPUY FRANCE
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46580 US
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Contact MEGAN BURNS
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Regulation Number

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Classification Product Code PHX
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Date Received 08/10/2012
Decision Date 09/06/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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