K253158
- 510(k) number
- K253158
- Device name
- VyBrate VBR System
- Applicant
- Vy Spine, LLC UT · US
- Product code
- MQP — Spinal Vertebral Body Replacement Device
- Decision date
- 2026-01-07
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253158.pdf
Official FDA record: K253158
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.