FDA 510(k) Applications Submitted by OSTEONIC CO., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K233659 |
11/15/2023 |
Suture Wing |
OSTEONIC Co., Ltd. |
| K210122 |
01/19/2021 |
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) |
Osteonic Co., Ltd. |
| K231322 |
05/08/2023 |
Fix2Lock(PEEK Self Punching) |
Osteonic Co., Ltd. |
| K231326 |
05/08/2023 |
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) |
Osteonic Co., Ltd. |
| K202763 |
09/21/2020 |
Fix2Lock (PEEK Self Punching) |
Osteonic Co., Ltd. |
| K202806 |
09/23/2020 |
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) |
OSTEONIC Co., Ltd. |
| K202663 |
09/14/2020 |
Suture Wing |
Osteonic Co., Ltd. |
| K230546 |
02/28/2023 |
SIGNEX |
OSTEONIC Co., Ltd. |
| K243469 |
11/08/2024 |
SIGNEX |
OSTEONIC Co., Ltd. |
| K160363 |
02/09/2016 |
OPTIMUS CMF SYSTEM |
OSTEONIC Co., Ltd. |
| K243467 |
11/08/2024 |
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) |
OSTEONIC Co., Ltd. |
| K243470 |
11/08/2024 |
Fix2Lock (PEEK Self Punching) |
Osteonic Co., Ltd. |
| K211992 |
06/28/2021 |
Ortho MI System |
Osteonic Co., Ltd. |
| K140037 |
01/07/2014 |
OPTIMUS CMF SYSTEM |
OSTEONIC CO., LTD. |
| K141911 |
07/15/2014 |
OPTIMUS NEURO SYSTEM |
OSTEONIC CO., LTD. |
| K202883 |
09/28/2020 |
Sterile bone screw (PEEK ACL screw) |
Osteonic Co., Ltd. |
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