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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 USA, INC.
PMA NumberP000058
Supplement NumberS054
Date Received10/25/2013
Decision Date12/06/2013
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for extension of the rhbmp-2 drug substance expiration date from 60 to 72 months using the approved expiration date modification protocol. The device, as modified, will be marketed under the trade name infuse bone graft/lt-cage lumbar tapered fusion devices and is indicated for the following: spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from l4-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history, function deficit and/or neurological deficit and radiographic studies. These ddd patients may also have up to grade i spondylolisthesis at the involved level. Infuse® bone graft/lt-cage devices are to be implanted via an open anterior or a laparoscopic approach. Patients receiving the infuse® bone graft/ lt-cage® lumbar tapered fusion device should have had at least six months of nonoperative treatment prior to treatment with the infuse® bone graft/lt-cage® device.
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