FDA 510(k) Application Details - K062426

Device Classification Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

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510(K) Number K062426
Device Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O BOX 988
WARSAW, IN 46581-0988 US
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Contact ANNE M SCHULER
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Regulation Number 888.3330

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Classification Product Code KWA
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Date Received 08/18/2006
Decision Date 12/15/2006
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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