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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 DEVICE WITH INSTRUMENTATION (20MM)
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namethreaded titanium holllow cylinder
Regulation Number888.3080
ApplicantUNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
PMA NumberP950019
Supplement NumberS003
Date Received05/15/1998
Decision Date06/17/1998
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of 20mm cages and modified labeling.
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