|Trade Name||LUMBAR I/F CAGE(R) SYSTEM|
|Classification Name||spinal pedicle screw, fixation, appliance system|
|Generic Name||interbody fusion device used with posterior pedicle screw fixation|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a wedged version of the i/f cage component. The indication for these implants has not been changed from that approved on february 2, 1999.