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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K182711
Device Name Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
Applicant
Kelyniam Global, Inc.
97 River Rd., Suite A
Canton,  CT  06019
Applicant Contact Eric Boyea
Correspondent
Kelyniam Global, Inc.
97 River Rd., Suite A
Canton,  CT  06019
Correspondent Contact Eric Boyea
Regulation Number882.5320
Classification Product Code
GWO  
Date Received09/27/2018
Decision Date 05/21/2019
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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