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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K113173
Device Name NANOVIS SPINAL SYSTEM
Applicant
NANOVIS, LLC
8202 sherman rd.
chesterland,  OH  44026 -2141
Applicant Contact karen e warden phd.
Correspondent
NANOVIS, LLC
8202 sherman rd.
chesterland,  OH  44026 -2141
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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