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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, facet screw spinal device
510(k) Number K113011
Device Name SPARTAN S3 FACET SYSTEM
Original Applicant
AMENDIA, INC.
13540 guild avenue
apple valley,  MN  55124
Original Contact rich jansen
Classification Product Code
MRW  
Date Received10/19/2011
Decision Date 12/06/2011
Decision substantially equivalent (SE)
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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