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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 III THREADED FUSION DEVICE
ApplicantSOFAMOR DANEK
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP970015
Supplement NumberS011
Date Received12/21/1999
Decision Date06/06/2000
Reclassified Date 07/12/2007
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITION OF HOLES IN THE ENDCAPS OF THE INTER FIX(TM) THREADED FUSION DEVICE.
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