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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namecervical interbody fusion instrumentation
Regulation Number888.3080
ApplicantSULZER SPINE-TECH
PMA NumberP980048
Supplement NumberS001
Date Received04/24/2001
Decision Date05/02/2001
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sterilization facility located at steris isomedix services, minneapolis, minnesota.
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