FDA 510(k) Application Details - K110836

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

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510(K) Number K110836
Device Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant ZIMMER GMBH
P.O. BOX 708
WARSAW, IN 46581-0708 US
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Contact DANIEL J WILLIMAN
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Regulation Number 888.3330

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Classification Product Code KWA
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Date Received 03/25/2011
Decision Date 10/07/2011
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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