510(k) K263113 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
ZSAlign Cervical Interbody System
| Applicant | ZSFab, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Oct 2, 2026 |
| Received | Sep 4, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K263113
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.