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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.
 
Trade NameLUMBAR I/F CAGE WITH VSP SPINE SYSTEM
Classification Namespinal pedicle screw, fixation, appliance system
Generic Nameinterbody fusion device used with posterior pedicle screw fixation
ApplicantDEPUY ACROMED
PMA NumberP960025
Supplement NumberS005
Date Received06/06/2000
Decision Date09/08/2000
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 changing the material of the i/f cage device component from injection molded pekekk with chopped carbon fibers in a fiber:matrix ratio of 30:70 to injection molded peek with chopped carbon fibers in a fiber:matrix ratio of 30:70.
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