K241783
- 510(k) number
- K241783
- Device name
- FortiVy OsteoVy Lumbar IBF
- Applicant
- Vy Spine, LLC UT · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-03-18
- Date received
- 2024-06-20
- 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: K241783.pdf
Official FDA record: K241783
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.