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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.
 
DeviceBAK INTERBODY FUSION SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
Applicant
Zimmer 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[ Registered Establishments with MAX ]
Docket Number 96M-0424
Notice Date 11/18/1996
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the bak interbody fusion system with instrumentation.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S014 
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