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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 K091973
Device Name METASUL TAPER LINERS, METASUL FEMORAL HEADS
Original Applicant
ZIMMER GMBH
p.o. box 708
warsaw,  IN  46581 0708
Original Contact benjamin c curson
Regulation Number888.3330
Classification Product Code
KWA  
Date Received07/01/2009
Decision Date 11/17/2009
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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