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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 THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantStryker Spine
2 Pearl Ct.
Allendale, NJ 07401
PMA NumberP950019
Supplement NumberS002
Date Received05/08/1998
Decision Date06/08/1998
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 additional instruments and a change to the surgical technique manual.
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