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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 NameZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
PMA NumberP060037
Supplement NumberS010
Date Received05/22/2009
Decision Date06/19/2009
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) adding a verification step to use a poke-yoke fixture to sort product during manufacturing; and 2) adding a step to verify the spiralock thread function.
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