• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
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.