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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 NumberS001
Date Received07/23/2002
Decision Date10/04/2002
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval clinical study for the device. The post-approval clinical study has been submitted to comply with the conditions of approval outlined in the july 2, 2002 approval order for p000058.
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