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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBAK/PROXIMITY(TM) 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
Supplement NumberS009
Date Received03/08/2001
Decision Date04/03/2001
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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