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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) DEVICE WITH INSTRUMENTATION
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameinterbody fusion device
Regulation Number888.3080
ApplicantCOVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
PMA NumberP950019
Supplement NumberS011
Date Received03/21/2000
Decision Date03/30/2000
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Removal of the post sterilization inspection for the ray threaded fusion cage with instrumentation.
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