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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 NameNOVUS TM LC THREADED INTERBODY FUSION DEVICE (TIBFD)
Generic Nameintervertebral body fusion device
ApplicantSOFAMOR DANEK
PMA NumberP970015
Supplement NumberS002
Date Received09/09/1998
Decision Date05/14/1999
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Supplement received prior to original approval. Supplement approved as part of the original approval order.
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