|Trade Name||SPF PLUS 60/W AND SPF-PLUS 60/M|
|Classification Name||stimulator, invasive bone growth|
|Generic Name||sdpf implantable spinal fusion stimulator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for device modifications to incorporate identical battery chemistry and implant tester configuration as approved in the spf-xl iib device. The device, as modified, will be marketed under the trade name spf-plus 60/w and spf-plus 60/m and is indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.