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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.
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namebak/rlp(bak/proxdimity(tm)) interbody fusion system
Regulation Number888.3080
PMA NumberP950002
Supplement NumberS009
Date Received03/08/2001
Decision Date04/03/2001
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the labeling of the bak interbody fusion system adding a precaution statement (ie. , the bak/proximity device is to be used only in conjunctino with a standard bak device. The safety and effectiveness of the bak/proximity device has not been established when used otherwise. ) effective april 1, 2001.