Optimus Neuro System— 510(k) K183352

Name: FDA 510(k) clearance K183352
Creator: U.S. Food and Drug Administration
Published: 2019-01-02

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K183352 for Optimus Neuro System, Substantially Equivalent on 2019-01-02. Applicant: Osteonic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code GWO
Device class: Class 2
Regulation: 21 CFR 882.5320
Advisory panel: Neurology
Date received: 2018-12-03
Decision date: 2019-01-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWO

view all

K262874 — CraniUS Plate2026-09-11
K261058 — CraniUS Plate2026-07-29
K250297 — TECHFIT Patient-Specific Cranial System2025-10-27
K250334 — Fusion Craniofacial Implant; Fusion Skull Implant2025-07-25
K231834 — VSP PEEK Cranial Implant2024-04-04

More clearances from Osteonic Co., Ltd.

view all

K254182 — Aster2026-02-26
K243469 — SIGNEX2025-05-29
K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)2024-12-03
K243470 — Fix2Lock (PEEK Self Punching)2024-12-03
K230546 — SIGNEX2024-06-11

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.