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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameRAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Namethreaded titanium holllow cylinder
Regulation Number888.3080
ApplicantSTRYKER SPINE
PMA NumberP950019
Date Received06/14/1995
Decision Date10/29/1996
Reclassified Date 07/12/2007
Product Code
MAX[ Registered Establishments with MAX ]
Docket Number 97M-0052
Notice Date 03/03/1997
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the ray threaded fusion cage (tfc) with instrumentation.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 
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