The following data is part of a premarket notification filed by U & I Corporation with the FDA for Seculok™ Suture Anchor.
| Device ID | K180759 |
| 510k Number | K180759 |
| Device Name: | SECULOK™ Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | U & I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Contact | Bo-ram Kang |
| Correspondent | Bo-ram Kang U & I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800037500137 | K180759 | 000 |
| 08800037500038 | K180759 | 000 |
| 08800037500045 | K180759 | 000 |
| 08800037500052 | K180759 | 000 |
| 08800037500069 | K180759 | 000 |
| 08800037500076 | K180759 | 000 |
| 08800037500083 | K180759 | 000 |
| 08800037500090 | K180759 | 000 |
| 08800037500106 | K180759 | 000 |
| 08800037500113 | K180759 | 000 |
| 08800037500120 | K180759 | 000 |
| 08800037500021 | K180759 | 000 |