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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namespinal pedicle screw, fixation, appliance system
Generic Namespinal pedicle screw, fixation, appliance system
PMA NumberP960025
Supplement NumberS011
Date Received08/04/2003
Decision Date03/05/2004
Product Code
MCV[ Registered Establishments with MCV ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product 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.