K253432 is an FDA 510(k) clearance for the DiversiVy™ Facet Screw System. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Vy Spine, LLC (Bountiful, US). The FDA issued a Cleared decision on March 19, 2026, 169 days after receiving the submission on October 1, 2025.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K253432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2025 |
| Decision Date | March 19, 2026 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW — System, Facet Screw Spinal Device |
| Device Class | — |