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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRAY TFC UNITE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameinterbody fusion device
Regulation Number888.3080
ApplicantSTRYKER SPINE
PMA NumberP950019
Supplement NumberS016
Date Received09/26/2003
Decision Date10/10/2003
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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