510(k) K253260 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
ORIO-3D Cage System
| Applicant | SpineCraft, Westmont IL, US |
| Decision | Substantially Equivalent, Apr 16, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253260
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.