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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 NameNATURAL KNEE & NATURAL KNEE II
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
ApplicantSULZERMEDICA
PMA NumberP940002
Supplement NumberS003
Date Received03/24/2000
Decision Date04/18/2000
Product Code
MBD[ Registered Establishments with MBD ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of forged ti alloy as a material for the construction of the stemmed tibial base plate component of the devices.
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