FDA 510(k) Application Details - K073499

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

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510(K) Number K073499
Device Name Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
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Contact ERIC S PITTMAN
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Regulation Number 888.3320

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Classification Product Code JDL
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Date Received 12/13/2007
Decision Date 08/07/2008
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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