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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.
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
1800 pyramid place
memphis, TN 38132
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 - indications/instructions/shelf life/tradename
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.