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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 NumberS004
Date Received06/13/1997
Decision Date06/30/1997
Reclassified Date07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF DESIGN CHANGES TO THE INSERTION END OF THE POLYETHYLENE ENDCAP AND THE INSERTION TOOLS USED AS PART OF THE BAK INTERBODY FUSION SYSTEM.
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