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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 INTERBODY FUSION SYSTEM
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantZimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis, MN 55439
PMA NumberP950002
Supplement NumberS001
Date Received12/26/1996
Decision Date07/22/1997
Reclassified Date07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO INCLUDE THE LAPAROSCOPIC SURGICAL APPROACH IN THE LABELING FOR THE BAK INTERBODY FUSION SYSTEM.
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