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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, Cervical
510(k) Number K140280
Device Name FORTICORE
Applicant
Nanovis, LLC
P.O. Box 566
Chesterland,  OH  44026
Applicant Contact KAREN E WARDEN PHD
Correspondent
Nanovis, LLC
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact KAREN E WARDEN PHD
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received02/04/2014
Decision Date 09/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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