K190067 is an FDA 510(k) clearance for the Velofix Interbody Fusion System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Cervical (Class II - Special Controls, product code ODP).
Submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on February 4, 2019, 20 days after receiving the submission on January 15, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K190067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2019 |
| Decision Date | February 04, 2019 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | ODP — Intervertebral Fusion Device With Bone Graft, Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |