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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 NameDUAL INTERFIX-RP(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 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 - instructions
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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