Cleared Traditional

OPTIMUS NEURO SYSTEM

K141911 · Osteonic Co., Ltd. · Neurology
Feb 2015
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K141911 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. (Fullerton, US). The FDA issued a Cleared decision on February 10, 2015, 210 days after receiving the submission on July 15, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K141911 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2014
Decision Date February 10, 2015
Days to Decision 210 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

Similar Devices — GWO Plate, Cranioplasty, Preformed, Alterable

All 41
TECHFIT Patient-Specific Cranial System
K250297 · Techfit Digital Surgery, Inc. · Oct 2025
Fusion Craniofacial Implant; Fusion Skull Implant
K250334 · Kelyniam Global, Inc. · Jul 2025
VSP PEEK Cranial Implant
K231834 · 3D Systems, Inc. · Apr 2024
MCI-Neuro Fixation System
K212391 · Mci Medical Concept Innovation, Inc. · Oct 2022
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
K210360 · Osteonic Co., Ltd. · Jan 2022
Stryker PEEK Customized Cranial Implant Kit
K203055 · Stryker · Feb 2021