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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.
 
DeviceRAY TFC DEVICE INSTRUMENTATION
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantStryker Spine
2 Pearl Ct.
Allendale, NJ 07401
PMA NumberP950019
Supplement NumberS005
Date Received10/20/1998
Decision Date10/29/1998
Reclassified Date07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modified instrument inserts.
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