K240326
- 510(k) number
- K240326
- Device name
- Solar Lumbar Interbody Fusion System
- Applicant
- Degen Medical, Inc. SC · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-07-29
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K240326.pdf
Official FDA record: K240326
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.