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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 K121551
Device Name RESOLUTE FACET SCREW SYSTEM
Original Applicant
NEUROSTRUCTURES, LLC
4628 northpark dr
colorado springs,  CO  80918
Original Contact meredith may
Classification Product Code
MRW  
Date Received05/30/2012
Decision Date 10/23/2012
Decision substantially equivalent (SE)
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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