FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VyBrate VBR System
K Number: K253158
·
Decision Jan 7, 2026
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
21
Review Days
103
Basic Information
- Device Name
- VyBrate VBR System
- K Number
- K253158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vy Spine, LLC
- Date Received
- September 26, 2025
- Decision Date
- January 7, 2026
- Product Code
- MQP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K233807 | LumiVy Lumbar IBF System | Sep 24, 2024 | Substantially Equivalent |
| K231836 | ClariVy Cervical IBF System | Oct 30, 2023 | Substantially Equivalent |
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| K232471 | Vy Spine VyLam Laminoplasty System | Oct 10, 2023 | Substantially Equivalent |
| K232167 | VySpan PCT System | Sep 27, 2023 | Substantially Equivalent |
| K230414 | ClariVy Cervical IBF System | May 12, 2023 | Substantially Equivalent |