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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained (metal uncemented acetabular component)
510(k) Number K071723
Device Name ZIMMER POROLOCK MIS STEM
Original Applicant
ZIMMER GMBH
p.o. box 708
warsaw,  IN  46581 0708
Original Contact dalene t binkley
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWL   KWY   KWZ  
LWJ   LZO  
Date Received06/25/2007
Decision Date 03/07/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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