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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 RP THREADED FUSION DEVICE
ApplicantSofamor Danek
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP970015
Supplement NumberS005
Date Received08/02/1999
Decision Date04/12/2000
Reclassified Date07/12/2007
Docket Number N
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the INTER FIX RP Threaded Fusion Device
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