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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantStryker Spine
2 Pearl Ct.
Allendale, NJ 07401
PMA NumberP950019
Date Received06/14/1995
Decision Date10/29/1996
Reclassified Date07/12/2007
Product Code MAX 
Docket Number 97M-0052
Notice Date 03/03/1997
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE RAY THREADED FUSION CAGE (TFC) WITH INSTRUMENTATION
Approval OrderApproval Order
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 
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