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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/RAY TFC UNITE DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameinterbody fusion device
Regulation Number888.3080
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP950019
Supplement NumberS012
Date Received02/11/2002
Decision Date04/02/2002
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 for the alif-open surgical technique for the ray tfc and ray tfc unite devices and revised labeling.
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