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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 Integrated Fixation, Lumbar
510(k) Number K182007
Device Name Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
Applicant
Renovis Surgical Technologies
1901 W. Lugonia Ave., Suite 340
Redlands,  CA  92374
Applicant Contact Anthony DeBenedictis
Correspondent
MEDIcept, Inc.
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Sharyn Orton
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Codes
ODP   OVE  
Date Received07/27/2018
Decision Date 12/07/2018
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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