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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 NumberS017
Date Received02/22/2005
Decision Date03/11/2005
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for use of new shipping container. The new container is lighter than the current container and uses polystyrene insulation instead of polyurethane.
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