Clearance Summary
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) received FDA 510(k) clearance under submission number K210360, sponsored by Osteonic Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-01-27.
- Submission: K210360
- Applicant / Sponsor: Osteonic Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5320
- Decision date: 2022-01-27
Classification & Regulation
This clearance is catalogued under FDA product code GWO and 21 CFR 882.5320, within the Neurology review panel as a Class II device.