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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 NumberS004
Date Received04/06/2000
Decision Date01/12/2001
Product Code
MCV[ Registered Establishments with MCV ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the lumbar i/f cage component of the lumbar i/f cage(r) with vsp(r) spine system with additional pedicle screw spinal systems. Specifically, for use with the following six additional posterior pedicle screw spinal systems: 1) the ti alloy version of the vsp spine system; 2) ti alloy and stainless steel versions of the isola spine system; 3) timx spine system; and 4) the ti alloy and stainless steel versions of the moss miami spine system. In addition, the device, as modified, will be marketed under the trade name lumbar i/f cage system. The indication for these implants has not been changed from that approved on february 2, 1999.