Fule Interbody Fusion Cage System— 510(k) K253151
Substantially EquivalentBeijing Fule Science & Technology Development Co., Ltd.
FDA 510(k) clearance K253151 for Fule Interbody Fusion Cage System, Substantially Equivalent on 2026-06-15. Applicant: Beijing Fule Science & Technology Development Co., Ltd.. Device class: 2.
Summary
Beijing Fule Science & Technology Development's Fule Interbody Fusion Cage System is filed under MAX, lumbar intervertebral fusion devices with bone graft. The record doesn't list cage sizes or components.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Fule filed from Beijing, China. The decision came 262 calendar days after receipt (September 26, 2025 to June 15, 2026).
Clearance details
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd.
- Product code
- Product code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code MAX
view allMore clearances from Beijing Fule Science & Technology Development Co., Ltd.
view allAdverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.