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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.
 
DeviceLT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
Applicant
SOFAMOR DANEK
1800 pyramid place
memphis, TN 38132
PMA NumberP970015
Supplement NumberS030
Date Received11/15/2004
Decision Date02/04/2005
Product Code
MAX[ Registered Establishments with MAX ]
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 inclusion of additional fusion cage component designs. Specifically, these design changes involved the incorporation of a rounded profile to the closed end of the tapered cage components. The modified tapered cage components can only be implanted via an anterior open surgical approach.
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