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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) 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 NumberS008
Date Received04/20/1999
Decision Date10/04/1999
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 ray tfc(tm) unite device, a modified version of the approved ray tfc(tm).
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