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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K172603
Device Name Cerafix Dura Substitute
Applicant
Acera Surgical, Inc.
10880 Baur Blvd.
St. Louis,  MO  63132
Applicant Contact Matthew MacEwan
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received08/30/2017
Decision Date 11/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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