Cleared Traditional

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

K182711 · Kelyniam Global, Inc. · Neurology
May 2019
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K182711 is an FDA 510(k) clearance for the Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI), a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by Kelyniam Global, Inc. (Canton, US). The FDA issued a Cleared decision on May 21, 2019, 236 days after receiving the submission on September 27, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K182711 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2018
Decision Date May 21, 2019
Days to Decision 236 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWO — Plate, Cranioplasty, Preformed, Alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5320

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