|Trade Name||SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)|
|Classification Name||stimulator, invasive bone growth|
|Generic Name||stimulator, invasive bone growth|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the trade name which was previously approved as: spf-plus (60/w) and spf- plus (60/m). The device will be marketed under the trade name spf plus-mini (60ua/w) and spf plus-mini (60ua/m) and is indicated as a spinal fusing adjunct to increase the probability of fusion success in 1 or 2 levels.