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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 NameLT-CAGE TAPERED FUSION DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral body fusion device
Regulation Number888.3080
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP970015
Supplement NumberS020
Date Received04/04/2002
Decision Date08/12/2002
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revised laparoscopic surgical technique for implantation of the lt-cage. The device remains marketed under the trade name lt-cage tapered fusion device and is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level form l2-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Lt-cage implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the lt-cage lumbar tapered fusion device should have had at least six months of nonoperative treatment prior treatment with the lt-cage.
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