Cleared Special

Optimus Neuro System

K183352 · Osteonic Co., Ltd. · Neurology
Jan 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K183352 is an FDA 510(k) clearance for the Optimus Neuro System, a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 2, 2019, 30 days after receiving the submission on December 3, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K183352 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2018
Decision Date January 02, 2019
Days to Decision 30 days
Submission Type Special
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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