510(k) K190618 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
RIGEL PEEK Anterior Cervical Interbody Fusion System
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, Jun 6, 2019 |
| Received | Mar 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190618
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.