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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 K193320
Device Name KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
Applicant
Kyocera Medical Technologies, Inc.
1200 California St.
Suite 210
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  
Date Received12/02/2019
Decision Date 02/04/2020
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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