The following data is part of a premarket notification filed by Osteonic Co., Ltd with the FDA 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).
| Device ID | K210360 |
| 510k Number | K210360 |
| Device Name: | 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) |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Osteonic Co., Ltd 1206Ho, 38, Digital-ro 29-gil, Guro-gu Seoul, KR 08381 |
| Contact | Na Young Kang |
| Correspondent | Sanglok Lee Wise Company Inc. #507, #508, 166 Gasan Digital 2-ro, Geumcheon-gu Seoul, KR 08507 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2022-01-27 |