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)— 510(k) K210360

Name: FDA 510(k) clearance K210360
Creator: U.S. Food and Drug Administration
Published: 2022-01-27

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K210360 for 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), Substantially Equivalent on 2022-01-27. 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: 2021-02-08
Decision date: 2022-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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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.