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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namelumbar interbody fusion instrumentation
Regulation Number888.3080
PMA NumberP950002
Date Received01/17/1995
Decision Date09/20/1996
Reclassified Date 07/12/2007
Product Code
MAX[ Registered Establishments with MAX ]
Docket Number 96M-0424
Notice Date 11/18/1996
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the bak interbody fusion system with instrumentation.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S014