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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 body fusion device
Regulation Number888.3080
PMA NumberP970015
Supplement NumberS022
Date Received10/30/2002
Decision Date09/10/2003
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the lt-cage peek lumber tapered fusion device, which is manufactured from polyetheretherke-tone, with the trade name of peek-optima lt1. The device, as modified, will be marketed under the trade name lt-cage peek lumbar tapered fusion device and is indicated for spinal fusion procedures in skeletally mature patients with degernerative disc disease (ddd) at one level from l2-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Lt-cage peek implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the lt-cage peek lumbar tapered fusion device should have at least six months of non-operative treatment prior treatment with the lt-cage peek device.