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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/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSulzer Spine-Tech
7375 Bush Lake Rd.
Minneapolis, MN 55439
PMA NumberP980048
Supplement NumberS001
Date Received04/24/2001
Decision Date05/02/2001
Reclassified Date07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS ISOMEDIX SERVICES, MINNEAPOLIS, MINNESOTA.
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