510(k) K260036 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
NeckTune 3D SA Cervical Cage
| Applicant | Medyssey Co, Ltd., Jecheon-Si, KR |
| Decision | Substantially Equivalent, Jun 15, 2026 |
| Received | Jan 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260036
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.