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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINTER FIX THREADED FUSION DEVICE
Applicant
SOFAMOR DANEK
1800 pyramid place
memphis, TN 38132
PMA NumberP970015
Supplement NumberS013
Date Received02/02/2000
Decision Date07/11/2000
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
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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