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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.
 
DeviceRAY THREADED FUSION CAGE(TFC)
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
Applicant
STRYKER SPINE
2 pearl court
allendale, NJ 07401
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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