The following data is part of a premarket notification filed by U&i Corporation with the FDA for Velofix(tm) Interbody Fusion System.
| Device ID | K171749 |
| 510k Number | K171749 |
| Device Name: | Velofix(tm) 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-13 |
| Decision Date | 2017-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800015946292 | K171749 | 000 |
| 08800015946179 | K171749 | 000 |
| 08800015946162 | K171749 | 000 |
| 08800015946155 | K171749 | 000 |
| 08800015946148 | K171749 | 000 |
| 08800015946131 | K171749 | 000 |
| 08800015946124 | K171749 | 000 |
| 08800015946117 | K171749 | 000 |
| 08800015946100 | K171749 | 000 |
| 08800015946186 | K171749 | 000 |
| 08800015946193 | K171749 | 000 |
| 08800015946209 | K171749 | 000 |
| 08800015946285 | K171749 | 000 |
| 08800015946278 | K171749 | 000 |
| 08800015946261 | K171749 | 000 |
| 08800015946254 | K171749 | 000 |
| 08800015946247 | K171749 | 000 |
| 08800015946230 | K171749 | 000 |
| 08800015946223 | K171749 | 000 |
| 08800015946216 | K171749 | 000 |
| 08800015946094 | K171749 | 000 |