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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
ApplicantSULZERMEDICA
PMA NumberP940002
Date Received01/14/1994
Decision Date03/21/1997
Reclassified Date 02/01/2003
Product Code
MBD[ Registered Establishments with MBD ]
Docket Number 97M-0252
Notice Date 06/30/1997
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the natural-knee(r) and natural knee(r) ii with csti(tm). These devices are indicated for uncemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result fo noninflammatory degenerative joint disease (nidjd) or inflammatory joint disease (ijd).
Supplements: S001 S002 S003 S005 
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