510(k) K172484 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
A-CIFT SoloFuse
| Applicant | Spinefrontier, Inc., Malden MA, US |
| Decision | Substantially Equivalent, May 8, 2018 |
| Received | Aug 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2019 | SpineFrontier, Inc. A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106) Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.