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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 NameBAK VISTA INTERBODY FUSION DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral body fusion device
Regulation Number888.3080
ApplicantCENTERPULSE SPINE-TECH, INC.
PMA NumberP950002
Supplement NumberS011
Date Received08/29/2002
Decision Date07/08/2003
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the bak vista interbody fusion device, which is manufactured from 65% peek optima and 35% toho besfight c6-uh carbon fiber, to the approved product line for the bak interbody fusion system. The device will be marketed under the trade name bak vista interbody fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (ddd) at the l2-s1 spinal levels. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level(s). Bak devices are to be implanted via an open anterior or posterior 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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