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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 NameX-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
ApplicantKYPHON, INC.
PMA NumberP040001
Supplement NumberS007
Date Received06/06/2007
Decision Date10/04/2007
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified version of the tissue expander of the titanium version of the x-stop spacer assembly.
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