|Trade Name||LUMBAR I/F CAGE WITH VSP SPINE SYSTEM|
|Classification Name||spinal pedicle screw, fixation, appliance system|
|Generic Name||spinal pedicle screw, fixation, appliance system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changing the material of the i/f cage device component from injection molded pekekk with chopped carbon fibers in a fiber:matrix ratio of 30:70 to injection molded peek with chopped carbon fibers in a fiber:matrix ratio of 30:70.