The following data is part of a premarket notification filed by U&i Corp. with the FDA for Velofixtm Interbody Fusion System.
| Device ID | K132926 |
| 510k Number | K132926 |
| Device Name: | VELOFIXTM INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | U&I CORP. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 480-859 |
| Contact | Gyeong Je-kwon |
| Correspondent | Gyeong Je-kwon U&I CORP. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 480-859 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-18 |
| Decision Date | 2014-03-05 |
| Summary: | summary |