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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.
 
DeviceDUAL INTERFIX-RP(TM) THREADED FUSION DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
Applicant
SOFAMOR DANEK
1800 pyramid place
memphis, TN 38132
PMA NumberP970015
Supplement NumberS019
Date Received04/09/2001
Decision Date07/19/2001
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 use of dual interfix-rp(tm) threaded fursion devices (instead of the already approved use of a single interfix-rp(tm) threaded fusion device used in conjunction with an interfix(tm) threaded fusion device) the unmodified device will continue to be marketed under the trade name interfix-rp(tm) threaded fusion device and is indicated for spinal fusion procedures in skeletally mature patients wtih 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. Interfix-rp(tm) threaded fusion devices are to be used with autogenous bone graft and implanted via an open anterior approach. Patients receiving the interfix-rp(tm) threaded fusion devices should have had at least six months of nonoperative treatment prior to treatment with the interfix-rp(tm) threaded fusion device.
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