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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 NameNEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
PMA NumberP060037
Supplement NumberS013
Date Received05/12/2010
Decision Date10/20/2010
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an inspection step for the fluted stem mobile tibial baseplate engraved line feature.
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