Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K141911
OPTIMUS NEURO SYSTEM · Osteonic Co., Ltd. · decided 2015-02-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Neuro Plating System | NBS304S05A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061856 |
| Neuro Plating System | NBP304X06A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061849 |
| Neuro Plating System | NBP304S06A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061818 |
| Neuro Plating System | N3D206M00A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809539691695 |
| Neuro Plating System | NSQ304M04A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061665 |
| Neuro Plating System | NST304L04A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061559 |
| Neuro Plating System | NGP204S06A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061788 |
| Neuro Plating System | NBS304X05A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061887 |
| Neuro Plating System | NST304M05A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061573 |
| Neuro Plating System | NGP204M06A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061795 |
| Neuro Plating System | N18006 | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809399745286 |
| Neuro Plating System | NDS304M06A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061702 |
| Neuro Plating System | NSQ304L04A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061672 |
| Neuro Plating System | NQD304M08A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061719 |
| Neuro Plating System | NTE204M00A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809595972691 |
| Neuro Plating System | NXP304M04A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061658 |
| Neuro Plating System | NST304M10A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061603 |
| Neuro Plating System | N15A04 | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809399745248 |
| Neuro Plating System | N18004 | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809399745279 |
| Neuro Plating System | NGP204L06A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061801 |
| Neuro Plating System | NSQ304X04A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061689 |
| Neuro Plating System | NBP304M06A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061825 |
| Neuro Plating System | NQD304L08A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061726 |
| Neuro Plating System | NST304X02A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061542 |
| Neuro Plating System | NST304M20A | OSTEONIC CO.,Ltd. | GWO GXR HBW | 08809416061627 |