FDA 510(k) Application Details - K092122

Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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510(K) Number K092122
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
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Contact RHONDA MYER
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Regulation Number 888.3660

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Classification Product Code KWS
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Date Received 07/14/2009
Decision Date 07/27/2009
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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