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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 TFC AND RAY TFC UNITE
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantStryker Spine
2 Pearl Ct.
Allendale, NJ 07401
PMA NumberP950019
Supplement NumberS014
Date Received02/13/2003
Decision Date03/25/2004
Reclassified Date07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRYKER SPINE, CESTAS, FRANCE.
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