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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, Lumbar
510(k) Number K192248
Device Name Cortina™ [MAX] Lumbar Cage System
Applicant
Neurostructures, Inc.
199 Technology Dr. Suite 110
Irvine,  CA  92618
Applicant Contact Moti Altarac
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith Lee May
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/19/2019
Decision Date 11/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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