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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 NameINFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Generic Nameinvertebral lumbar device
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
PMA NumberP000058
Supplement NumberS002
Date Received10/24/2002
Decision Date07/29/2004
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for 1) the extension of the levels of use of the device from l4-s1 to l2-s1 2) modification of the indication to allow for the device to be used in subjects who may have retrolisthesis in conjunction with degenerative disc disease 3) change in storage temperature limit and 4) revisions to instruction for use.
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