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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K113625
Device Name DSS STABILIZATION SYSTEM
Original Applicant
PARADIGM SPINE, LLC
1331 h street nw
12th floor
washington,  DC  20005
Original Contact michelle mcdonough
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received12/12/2011
Decision Date 01/10/2012
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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