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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBAK INTERBODY FUSION SYSTEM
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantZimmer Spine, Inc
7375 Bush Lake Road
Minneapolis, MN 55439
PMA NumberP950002
Date Received01/17/1995
Decision Date09/20/1996
Reclassified Date 07/12/2007
Product Code MAX 
Docket Number 96M-0424
Notice Date 11/18/1996
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE BAK INTERBODY FUSION SYSTEM WITH INSTRUMENTATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 
S013 S014 
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