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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K163457
Device Name NeuraGen 3D Nerve Guide Matrix
Applicant
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact Gabriella Green
Correspondent
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact Gabriella Green
Regulation Number882.5275
Classification Product Code
JXI  
Date Received12/09/2016
Decision Date 01/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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