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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
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSOFAMOR DANEK
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP970015
Supplement NumberS027
Date Received03/19/2004
Decision Date04/16/2004
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE ELIMINATION OF THE REAMING STEP IN THE SURGICAL IMPLANTATION PROCEDURES FOR THE LT CAGE PEEK LUMBAR TAPERED FUSION DEVICE, THE LT CAGE LUMBER TAPERED FUSION DEVICE, AND THE INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE.
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