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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 K113173
Device Name NANOVIS SPINAL SYSTEM
Original Applicant
NANOVIS, LLC
8202 sherman rd.
chesterland,  OH  44026 2141
Original Contact karen e warden phd.
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received10/27/2011
Decision Date 01/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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