Fule Metallic Lockable Intramedullary Nail Systems— 510(k) K253155
Substantially EquivalentBeijing Fule Science & Technology Development Co., Ltd.
FDA 510(k) clearance K253155 for Fule Metallic Lockable Intramedullary Nail Systems, Substantially Equivalent on 2026-06-17. Applicant: Beijing Fule Science & Technology Development Co., Ltd.. Device class: 2.
Summary
Beijing Fule Science & Technology Development's Fule Metallic Lockable Intramedullary Nail Systems are filed under HSB, intramedullary fixation rods and accessories. The name uses the plural "Systems," but the record doesn't list them or their components.
Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Fule filed from Beijing, China. The decision came 264 calendar days after FDA received it (September 26, 2025 to June 17, 2026).
Clearance details
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd.
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code HSB
view allMore clearances from Beijing Fule Science & Technology Development Co., Ltd.
view allAdverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.