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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K161485
Device Name Nanovis Intervertebral Body Fusion System and Forticore(R)
Applicant
NANOVIS LLC
5865 EAST STATE RD. 14
COLUMBIA CITY,  IN  46725
Applicant Contact MATTHEW HEDRICK
Correspondent
BACKROADS CONSULTING INC.
PO BOX 566
CHESTERLAND,  OH  44026 2141
Correspondent Contact KAREN E. WARDEN
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received05/31/2016
Decision Date 09/06/2016
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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