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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K153097
Device Name Belvedere™ Lateral Plating System
Applicant
Neurostructures, Inc.
16 Technology Dr. Suite 165
Irvine,  CA  92618
Applicant Contact Moti Altarac
Correspondent
Empirical Testing Corporation
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C Maxwell
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/26/2015
Decision Date 07/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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