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Osteonic Co., Ltd. FDA Approvals
0 new drug approvals and 14 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Aster510(k)Feb 26, 2026Orthopedic |
| SIGNEX510(k)May 29, 2025Orthopedic |
| Fix2Lock (PEEK Self Punching)510(k)Dec 3, 2024Orthopedic |
| Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)510(k)Dec 3, 2024Orthopedic |
| SIGNEX510(k)Jun 11, 2024Orthopedic |
| Suture Wing510(k)Dec 26, 2023Orthopedic |
| Fix2Lock(PEEK Self Punching)510(k)Jun 7, 2023Orthopedic |
| Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)510(k)May 31, 2023Orthopedic |
| 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)510(k)Jan 27, 2022Neurology |
| Ortho MI System510(k)Oct 15, 2021Dental |
| Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)510(k)Aug 27, 2021Orthopedic |
| Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)510(k)Jun 17, 2021Orthopedic |
| Suture Wing510(k)Jun 7, 2021Orthopedic |
| Fix2Lock (PEEK Self Punching)510(k)Jun 4, 2021Orthopedic |