Cleared Traditional

Optimus NEURO System - Sterile Kit

K190811 · Osteonic Co., Ltd. · Neurology
Nov 2019
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K190811 is an FDA 510(k) clearance for the Optimus NEURO System - Sterile Kit, 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 November 27, 2019, 243 days after receiving the submission on March 29, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K190811 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2019
Decision Date November 27, 2019
Days to Decision 243 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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