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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 THREADED FUSION DEVICE
Generic Nameintervertebral body fusion device
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP970015
Supplement NumberS013
Date Received02/02/2000
Decision Date07/11/2000
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 of a post approval study for the inter fix(tm) threaded fusion device.
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