|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 Name||FLEX MOBILE BEARING KNEE|
|Classification Name||prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at zimmer orthopedic mfg ltd. (aolm), in shannon industrial estate, ireland and a sterilization site located at isotron, westport, ireland.