Osteonic Co., Ltd.
Medical device manufacturer in Seoul, KR.
20510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254182 | AsterKWQ · Traditional | 02/26/2026SE |
| K243469 | SignexHRS · Traditional | 05/29/2025SE |
| K243470 | Fix2Lock (PEEK Self Punching)MBI · Special | 12/03/2024SE |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI · Special | 12/03/2024SE |
| K230546 | SignexHRS · Traditional | 06/11/2024SE |
| K233659 | Suture WingMBI · Special | 12/26/2023SE |
| K231322 | Fix2Lock(PEEK Self Punching)MBI · Special | 06/07/2023SE |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAI · Special | 05/31/2023SE |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional | 01/27/2022SE |
| K211992 | Ortho MI SystemOAT · Traditional | 10/15/2021SE |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)MAI · Traditional | 08/27/2021SE |
| K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI · Traditional | 06/17/2021SE |
| K202663 | Suture WingMBI · Traditional | 06/07/2021SE |
| K202763 | Fix2Lock (PEEK Self Punching)MBI · Traditional | 06/04/2021SE |
| K202883 | Sterile bone screw (PEEK ACL screw)MBI · Traditional | 11/25/2020SE |
| K190811 | Optimus NEURO System - Sterile KitGWO · Traditional | 11/27/2019SE |
| K183352 | Optimus Neuro SystemGWO · Special | 01/02/2019SE |
| K160363 | Optimus CMF SystemJEY · Special | 10/20/2016SE |
| K141911 | Optimus Neuro SystemGWO · Traditional | 02/10/2015SE |
| K140037 | Optimus CMF SystemJEY · Traditional | 01/20/2015SE |