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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 RP THREADED FUSION DEVICE-REDUCED PROFILE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral body fusion device
Regulation Number888.3080
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP970015
Supplement NumberS017
Date Received09/28/2000
Decision Date12/13/2000
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the interfix(tm) rp threaded fusion device to be also known as the interfix(tm) rp threaded fusion device - reduced profile. The device will now be marketed under both trade names and will remain indicated for use with autogenous bone braft in patients with degenerative disc disease (ddd) at one level from l2-s1. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. The device is to be implanted via an open anterior approach. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
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