|Trade Name||SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE|
|Classification Name||spinal pedicle screw, fixation, appliance system|
|Generic Name||interbody fusion device used with posterior pedicle screw fixation|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the saber lumber i/f cage. In addition, this supplement requested the approval of two new sizes, which will now be marketed as the jaguar lumbar i/f cage. These devices are indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (ddd) at one or two spinal levels from l2-s1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360 degrees fusion) and posterior pedicle screw fixation. These patients may have had previous non-fusion spinal surgery at the involved spinal levels(s). Ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.