K250773
- 510(k) number
- K250773
- Device name
- Luna® Ti Interbody Fusion System
- Applicant
- Spinal Elements, Inc. CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-02-04
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250773.pdf
Official FDA record: K250773
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.