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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
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 NumberS027
Date Received03/19/2004
Decision Date04/16/2004
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the elimination of the reaming step in the surgical implantation procedures for the lt cage peek lumbar tapered fusion device, the lt cage lumber tapered fusion device, and the infuse bone graft/lt cage lumbar tapered fusion device.
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