510(k) K191477 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
AEON-C Stand Alone System
| Applicant | Huvexel Co. , Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Nov 13, 2019 |
| Received | Jun 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191477
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.