510(k) K253158
K253158 is an FDA 510(k) premarket notification submitted by Vy Spine, LLC for the device "VyBrate VBR System". The FDA issued a decision of Substantially Equivalent on January 7, 2026. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Vy Spine, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2026
- Date Received
- September 26, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Vertebral Body Replacement Device
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type