K233807
- 510(k) number
- K233807
- Device name
- LumiVy Lumbar IBF System
- Applicant
- Vy Spine, LLC UT · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-24
- Date received
- 2023-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233807.pdf
Official FDA record: K233807
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.