Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 SPACER SYSTEM
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
ApplicantMEDTRONIC SPINE LLC.
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.
-
-