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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 AND RAY TFC UNITE DEVICE
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral body fusion device
Regulation Number888.3080
ApplicantCOVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
PMA NumberP950019
Supplement NumberS009
Date Received05/03/1999
Decision Date03/02/2000
Product Code
MAX[ Registered Establishments with MAX ]
Docket Number 00M-1212
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Modified indications for use for the ray tfc and unite threaded fusion cage with instrumentation. These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (ddd) at one or two levels for l2 to s1.
Approval Order Approval Order
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