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

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device prosthesis, spinous process spacer/plate
Definition This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
Review Panel Orthopedic
Product CodeNQO
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-