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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTRILOGY AB ACETABULAR SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis hip,semi-constrained,metal/ceramic/metal,cemented or uncemented
ApplicantZIMMER, INC.
PMA NumberP040048
Supplement NumberS011
Date Received12/14/2009
Decision Date01/11/2010
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate test method for x-ray diffraction determination (xrd) of phase content of the plasma-sprayed hydroxyapatite coatings as well as addition of two new contract testing facilities (lambda technologies in cincinnati, ohio and evans analytical group (eag) in round rock, texas).
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