510(k) K172424 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Velofix SA Cervical Cage
| Applicant | U&I Corporation, Uijeongbu-Si, KR |
| Decision | Substantially Equivalent, Nov 22, 2017 |
| Received | Aug 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172424
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2019 | U&I CORP. Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion pro Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.