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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) (R) 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 NumberS002
Date Received06/22/2001
Decision Date06/19/2002
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study protocol for the bac/c device. The post-approval study has been submitted to comply with the conditions of approval outlined in the april 20, 2001, approval order for p980048.
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