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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
325 paramont drive
raynham, MA 02767
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.