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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.
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
PMA NumberP040001
Supplement NumberS016
Date Received11/05/2009
Decision Date04/30/2010
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Clinical Trials NCT00517751
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional surgical instruments, changes to existing instruments and a new sterilization tray. These new components include the sizing distractor, the spacer insertion instrument with tri-lobe connectors, the bi-directional sizing distractor, the horizontal handle, the trial spacers, and the two-level sterilization tray.