510(k) K253876 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
HEDRON Cervical Spacers (HEDRON C-MIS Spacer)
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Dec 4, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253876
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.