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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 NameINTER FIX III THREADED FUSION DEVICE
Generic Nameintervertebral body fusion device
ApplicantSOFAMOR DANEK
PMA NumberP970015
Supplement NumberS011
Date Received12/21/1999
Decision Date06/06/2000
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 
Approval for addition of holes in the endcaps of the inter fix(tm) threaded fusion device.
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