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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 K121850
Device Name CHOICE SPINE FIXATION SYSTEM
Original Applicant
CHOICE SPINE, LP
400 erin dr
knoxville,  TN  37919
Original Contact kim finch
Classification Product Code
MRW  
Date Received06/25/2012
Decision Date 09/20/2012
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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