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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 NameVISTA LORDOTIC INTERBODY FUSION CAGE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral body fusion device
Regulation Number888.3080
ApplicantCENTERPULSE SPINE-TECH, INC.
PMA NumberP950002
Supplement NumberS013
Date Received12/24/2003
Decision Date01/29/2004
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the vista lordotic device to the approved product line for the bak interbody fusion system. The device will be marketed under the trade name vista lordotic and is indicated for use with autogenous bone graft in patients with degenerative disc disease (ddd) at one or two continuous levels from l4-l5 and/or l5-s1. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level(s). 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. Vista lordotic devices are to be implanted via an open anterior approach.
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