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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.
 
DeviceLT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSofamor Danek
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP970015
Supplement NumberS030
Date Received11/15/2004
Decision Date02/04/2005
Reclassified Date07/12/2007
Product Code MAX 
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 INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS. SPECIFICALLY, THESE DESIGN CHANGES INVOLVED THE INCORPORATION OF A ROUNDED PROFILE TO THE CLOSED END OF THE TAPERED CAGE COMPONENTS. THE MODIFIED TAPERED CAGE COMPONENTS CAN ONLY BE IMPLANTED VIA AN ANTERIOR OPEN SURGICAL APPROACH.
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