|Trade Name||EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR|
|Classification Name||stimulator, invasive bone growth|
|Generic Name||invasive bone growth stimulator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the spf-xl iib implantable spinal fusion stimulator which is a modification of the spf-xl ii implantable spinal fusion stimulator. The spf-xl iib implantable spinal fusion stimulator has a smaller generator case than the spf-xl ii implantalble spinal fusion stimulator. The device, as modified, will be marketed under the trade name the spf-xl iib implantable spinal fusion stimulator and is indicated for use as a spinal fusion adjunct to increase the probability of fusion success in 3 or more levels.