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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 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.