The following data is part of a premarket notification filed by U&i Corp. with the FDA for Veloxtm Interbody Fusion System.
| Device ID | K140864 |
| 510k Number | K140864 |
| Device Name: | VELOXTM 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 | Ji Yea Lee |
| Correspondent | Ji Yea Lee 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 | 2014-04-03 |
| Decision Date | 2014-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800015913522 | K140864 | 000 |
| 08800015913515 | K140864 | 000 |
| 08800015913362 | K140864 | 000 |
| 08800015913287 | K140864 | 000 |
| 08800015913270 | K140864 | 000 |
| 08800015913126 | K140864 | 000 |
| 08800015913041 | K140864 | 000 |
| 08800015913034 | K140864 | 000 |