The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Suture Wing.
| Device ID | K202663 |
| 510k Number | K202663 |
| Device Name: | Suture Wing |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Osteonic Co., Ltd. 38 Digital-ro 29-gil Guro-gu, KR 08381 |
| Contact | Dakyung Ham |
| Correspondent | Sanglok Lee Wise Company Inc. #303, 142, Gasan Digital 1-ro Geumcheon-gu, KR 08507 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2021-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800071005179 | K202663 | 000 |
| 08800071005094 | K202663 | 000 |
| 08800071005100 | K202663 | 000 |
| 08800071005117 | K202663 | 000 |
| 08800071005124 | K202663 | 000 |
| 08800071005131 | K202663 | 000 |
| 08800071005148 | K202663 | 000 |
| 08800071005155 | K202663 | 000 |
| 08800071005162 | K202663 | 000 |
| 08800071005087 | K202663 | 000 |