The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Sterile Bioabsorbable Bone Screw (bioabsorbable Acl Screw).
| Device ID | K210122 |
| 510k Number | K210122 |
| Device Name: | Sterile Bioabsorbable Bone Screw (Bioabsorbable ACL Screw) |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Osteonic Co., Ltd. 39 Digital-ro 29-gil Guro-gu, KR 08381 |
| Contact | Da Kyung Ham |
| Correspondent | Sanglok Lee Wise Company Inc. #507, #508, 166 Gasan Digital 2-ro Geumcheon-gu, KR 08507 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800071020929 | K210122 | 000 |
| 08800071020806 | K210122 | 000 |
| 08800071020813 | K210122 | 000 |
| 08800071020820 | K210122 | 000 |
| 08800071020837 | K210122 | 000 |
| 08800071020844 | K210122 | 000 |
| 08800071020851 | K210122 | 000 |
| 08800071020868 | K210122 | 000 |
| 08800071020875 | K210122 | 000 |
| 08800071020882 | K210122 | 000 |
| 08800071020899 | K210122 | 000 |
| 08800071020905 | K210122 | 000 |
| 08800071020912 | K210122 | 000 |
| 08800071020790 | K210122 | 000 |