FDA 510(k) Application Details - K060874

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

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510(K) Number K060874
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW, IN 46581-0988 US
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Contact NATALIE S HECK
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Regulation Number 888.3660

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Classification Product Code KWS
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Date Received 03/30/2006
Decision Date 06/28/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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