The following data is part of a premarket notification filed by U&i Corporation with the FDA for Seculok™ Acp System.
| Device ID | K182055 |
| 510k Number | K182055 |
| Device Name: | SECULOK™ ACP System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | U&i Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Contact | Kwang-eun Song |
| Correspondent | Kwang-eun Song U&i Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-31 |
| Decision Date | 2018-09-10 |
| Summary: | summary |