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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)
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 NumberS010
Date Received09/27/1999
Decision Date12/01/1999
Product Code
MAX[ Registered Establishments with MAX ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the sulzer spine-tech facility located at 8990 springbrook drive, #10, minneapolis, minnesota 55433 as an alternate site for assembly, packaging and quality control of the device and the biotest laboratories, inc. , located at 7375 bush lake rd. , minneapolis, minnesota 55439 as an alternate site for assembly, packaging and labeling of the device.
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