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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.
 
DeviceCOFLEX® INTERLAMINAR TECHNOLOGY
Generic NameProsthesis, spinous process spacer/plate
ApplicantXtant Medical Holdings, Inc.
664 Cruiser Lane
Belgrade, MT 59714
PMA NumberP110008
Date Received03/03/2011
Decision Date10/17/2012
Product Code NQO 
Docket Number 12M-1085
Notice Date 11/08/2012
Advisory Committee Orthopedic
Clinical TrialsNCT00534235
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE COFLEX INTERLAMINAR TECHNOLOGY. THIS DEVICE IS INDICATED FOR USE IN ONE- OR TWO-LEVEL LUMBAR STENOSIS FROM L1- L5 IN SKELETALLY MATURE PATIENTS WITH AT LEAST MODERATE IMPAIRMENT IN FUNCTION, WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCKS/ GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND WHO HAVE UNDERGONE AT LEAST 6 MONTH OF NON-OPERATIVE TREATMENT. THE COFLEX IS INTENDED TO BE IMPLANTED MIDLINE BETWEEN ADJACENT LAMINA OF 1 OR 2 CONTIGUOUS LUMBAR MOTION SEGMENTS. INTERLAMINAR STABILIZATION IS PERFORMED AFTER DECOMPRESSION OF STENOSIS AT THE AFFECTED LEVEL(S).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 
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