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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 UNITE
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSTRYKER SPINE
2 Pearl Court
Allendale, NJ 07401
PMA NumberP950019
Supplement NumberS016
Date Received09/26/2003
Decision Date10/10/2003
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR LABELING CHANGES (CHANGE OF ADDRESS, CHANGE IN CE MARK, ADDITIONAL PATENT STATEMENT) AND CHANGES IN PART NUMBERS.
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