510(k) K210360 ยท GWO Plate, Cranioplasty, Preformed, Alterable
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)
| Applicant | Osteonic Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jan 27, 2022 |
| Received | Feb 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210360
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.