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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 PEEK LUMBAR 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 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.
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