K253151
- 510(k) number
- K253151
- Device name
- Fule Interbody Fusion Cage System
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd. CN
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-06-15
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K253151.pdf
Official FDA record: K253151
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.