|Trade Name||NOVUS TM LC THREADED INTERBODY FUSION DEVICE (TIBFD)|
|Generic Name||intervertebral body fusion device|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Supplement received prior to original approval. Supplement approved as part of the original approval order.