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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
Applicant
ZIMMER GMBH
p.o. box 708
warsaw,  IN  46581 0708
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
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