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 manual instruments designed for use with non-fusion spinous process tension band implant
Definition The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process tension band implant for non-fusion use.
Physical State Manual, non-powered surgical tools with implant-specific geometry.
Technical Method Manual surgical instrument that assembles to the associated implant or has features that manipulate tissue to reproduce the geometry of the associated implant.
Target Area Spinous process.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeSGL
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.4520
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-