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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 THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
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 NumberS002
Date Received05/08/1998
Decision Date06/08/1998
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional instruments and a change to the surgical technique manual.
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