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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 NameINTER FIX TM THREADED 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 NumberS031
Date Received01/28/2005
Decision Date07/27/2005
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post approval study. The device remains indicated for spinal fusion procedures in skeletally mature patients with degenerative 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 may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Inter fix implants and inter fix rp implants are to be used with autogenous bone graft and implanted via an open anterior approach.
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