The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Fix2lock (peek Self Punching).
| Device ID | K202763 |
| 510k Number | K202763 |
| Device Name: | Fix2Lock (PEEK Self Punching) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Osteonic Co., Ltd. 38 Digital-ro 29-gil Guro-gu, KR 08381 |
| Contact | Da Kyung 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 | 2020-09-21 |
| Decision Date | 2021-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809595976996 | K202763 | 000 |
| 08809595976880 | K202763 | 000 |
| 08809595976835 | K202763 | 000 |
| 08809595976828 | K202763 | 000 |
| 08809595976811 | K202763 | 000 |
| 08809595976804 | K202763 | 000 |
| 08809595976774 | K202763 | 000 |
| 08809595976675 | K202763 | 000 |
| 08809595976392 | K202763 | 000 |
| 08809595976897 | K202763 | 000 |
| 08809595976903 | K202763 | 000 |
| 08809595976989 | K202763 | 000 |
| 08809595976972 | K202763 | 000 |
| 08809595976965 | K202763 | 000 |
| 08809595976958 | K202763 | 000 |
| 08809595976941 | K202763 | 000 |
| 08809595976934 | K202763 | 000 |
| 08809595976927 | K202763 | 000 |
| 08809595976910 | K202763 | 000 |
| 08809595976385 | K202763 | 000 |