The following data is part of a premarket notification filed by U&i Corporation with the FDA for Velofix Interbody Fusion System.
| Device ID | K190067 |
| 510k Number | K190067 |
| Device Name: | Velofix Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | U&i Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Contact | Jee-ae Bang |
| Correspondent | Jee-ae Bang U&i Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-15 |
| Decision Date | 2019-02-04 |
| Summary: | summary |