510(k) K253158 · MQP Spinal Vertebral Body Replacement Device
VyBrate VBR System
| Applicant | Vy Spine, LLC, Bountiful UT, US |
| Decision | Substantially Equivalent, Jan 7, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253158
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.