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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-TM) DEVICE WITH INSTRUMENTATION
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantStryker Spine
2 Pearl Ct.
Allendale, NJ 07401
PMA NumberP950019
Supplement NumberS011
Date Received03/21/2000
Decision Date03/30/2000
Reclassified Date07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REMOVAL OF THE POST STERILIZATION INSPECTION FOR THE RAY THREADED FUSION CAGE WITH INSTRUMENTATION.
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