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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.
 
DeviceRAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
Classification Nameintervertebral fusion device with bone graft, lumbar
Generic Nameintervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
Applicant
STRYKER SPINE
2 pearl court
allendale, NJ 07401
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
Recalls CDRH Recalls
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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