Cleared Traditional

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. · Neurology

Jan 2022

Decision

353d

Days

Class 2

Risk

About This 510(k) Submission

K210360 is an FDA 510(k) clearance for the 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), 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 27, 2022, 353 days after receiving the submission on February 8, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number	K210360 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2021
Decision Date	January 27, 2022
Days to Decision	353 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF