Osteonic Co., Ltd.
FDA 510(k) & PMA Approved Devices — 18 products
Total Devices18
Categories7
Latest FDA decision2026-02-26
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K254182 | Aster | KWQ | 2026-02-26 | View |
| 510(k) | K243469 | SIGNEX | HRS | 2025-05-29 | View |
| 510(k) | K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | MAI | 2024-12-03 | View |
| 510(k) | K243470 | Fix2Lock (PEEK Self Punching) | MBI | 2024-12-03 | View |
| 510(k) | K230546 | SIGNEX | HRS | 2024-06-11 | View |
| 510(k) | K233659 | Suture Wing | MBI | 2023-12-26 | View |
| 510(k) | K231322 | Fix2Lock(PEEK Self Punching) | MBI | 2023-06-07 | View |
| 510(k) | K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) | MAI | 2023-05-31 | View |
| 510(k) | K210360 | 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) | GWO | 2022-01-27 | View |
| 510(k) | K211992 | Ortho MI System | OAT | 2021-10-15 | View |
| 510(k) | K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | MAI | 2021-08-27 | View |
| 510(k) | K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | MAI | 2021-06-17 | View |
| 510(k) | K202663 | Suture Wing | MBI | 2021-06-07 | View |
| 510(k) | K202763 | Fix2Lock (PEEK Self Punching) | MBI | 2021-06-04 | View |
| 510(k) | K202883 | Sterile bone screw (PEEK ACL screw) | MBI | 2020-11-25 | View |
| 510(k) | K190811 | Optimus NEURO System - Sterile Kit | GWO | 2019-11-27 | View |
| 510(k) | K183352 | Optimus Neuro System | GWO | 2019-01-02 | View |
| 510(k) | K160363 | OPTIMUS CMF SYSTEM | JEY | 2016-10-20 | View |
No matching devices.