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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 INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namelumbar interbody fusion instrumentation
Regulation Number888.3080
ApplicantSULZER SPINE-TECH
PMA NumberP950002
Supplement NumberS007
Date Received02/11/1999
Decision Date05/01/2002
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the bp/lordotic to the approved product line for the bak interbody fusion system. The device, as modified, will be marketed under the trade name bp/lordotic and is indicated for use with autogenous bone graft in patients with degenerative disc disease (ddd) at the l4-l5 and/or l5-s1 levels. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level(s). Bp/lordotic devices are to be implanted via an open anterior or laparoscopic 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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