|Trade Name||SPINAL-STIM LITE SPINAL FUSION SYSTEM|
|Classification Name||stimulator, bone growth, non-invasive|
|Generic Name||non-invasive bone growth stimulator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the spinal-stim(r) lite spinal fusion system, model 212l. The device will be marketed under the trade name spinal-stim(r) and is indicated as a spinal fusion adjunct to increase the probability of fusion success ans as a nonooperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.