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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 DEVICE AND RAY TFC UNITE DEVICE
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSTRYKER SPINE
2 Pearl Court
Allendale, NJ 07401
PMA NumberP950019
Supplement NumberS009
Date Received05/03/1999
Decision Date03/02/2000
Reclassified Date 07/12/2007
Product Code MAX 
Docket Number 00M-1212
Advisory Committee Orthopedic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modified indications for use for the Ray TFC and Unite Threaded Fusion Cage with instrumentation. These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (DDD) at one or two levels for L2 to S1.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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