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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 K173082
Device Name Arco™-SA Lumbar Cage System
Applicant
Neurostructures, Inc.
16 Technology Dr. Suite 165
Irvine,  CA  92618
Applicant Contact Kathleen Wong
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith L. May
Regulation Number888.3080
Classification Product Code
OVD  
Date Received09/29/2017
Decision Date 03/29/2018
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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