|Trade Name||SPINAL-STIM(R) MODEL 8212C|
|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 model 8000c control unit which is to be used in conjunction with the existing model 212 treatment transducers, and for minor modifications to the labeling of the physician manual regarding patient compliance data retrieval and erasure. The device will be marketed under the trade name spinal-stim(r) and is indicated as a surgical adjunct for spinal fusion or as a nonoperative treatment where at least nine months have elapsed since the last surgery.