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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRAY THREADED FUSION CAGE(TFC)
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSTRYKER SPINE
2 Pearl Court
Allendale, NJ 07401
PMA NumberP950019
Supplement NumberS010
Date Received09/27/1999
Decision Date12/01/1999
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
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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