The following data is part of a premarket notification filed by U&i Corporation with the FDA for Aspiron S Acp System.
| Device ID | K220147 |
| 510k Number | K220147 |
| Device Name: | Aspiron S ACP System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Contact | So-yeon Jang |
| Correspondent | So-yeon Jang 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-19 |
| Decision Date | 2022-02-16 |