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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceTRILOGY AB ACETABULAR SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
ZIMMER, INC.
p.o. box 708
warsaw, IN 46581-0708
PMA NumberP040048
Date Received12/14/2004
Decision Date06/28/2006
Withdrawal Date 08/29/2012
Product Code
MRA[ Registered Establishments with MRA ]
Docket Number 07M-0259
Notice Date 06/28/2007
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the trilogy ab acetabular system. The device is indicated for either cemented or noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (nidjd) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S008 S009 S010 S011 
S012 S014 S015 S016 S017 
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