FDA 510(k) Application Details - K081007

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

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510(K) Number K081007
Device Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
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Contact BENJAMIN C CURSON
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Regulation Number 888.3330

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Classification Product Code KWA
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Date Received 04/08/2008
Decision Date 05/06/2008
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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