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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.
 
DeviceNATURAL KNEE & NATURAL KNEE II
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Applicant
SULZERMEDICA
9900 spectrum dr.
austin,, TX 78717
PMA NumberP940002
Supplement NumberS003
Date Received03/24/2000
Decision Date04/18/2000
Product Code
MBD[ Registered Establishments with MBD ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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