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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 NumberS001
Date Received03/18/1997
Decision Date04/11/1997
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
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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