# Beijing Fule Science & Technology Development Co., Ltd.

- Location (FDA's records): Beijing, CN
- FDA decisions: 4 (2025–2026): 4 510(k) clearances
- Product codes: NKB (1), HRX (1), MAX (1), HSB (1)
- 510(k) review time since 2016: median 240 days, against 123 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- A-Spine Asia, Co., Ltd.: 1 (https://510kreport.com/company/a-spine-asia)
- Jiangsu Changmei Medtech Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-changmei-medtech)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Double Medical Technology, Inc.: 1 (https://510kreport.com/company/double-medical-technology)
- DePuy Synthes: 1 (https://510kreport.com/company/depuy-synthes)

## Recent decisions
- K260203: Fule Vertebroplasty Balloon Catheter (Aug 28, 2026)
- K253155: Fule Metallic Lockable Intramedullary Nail Systems (Jun 17, 2026)
- K253151: Fule Interbody Fusion Cage System (Jun 15, 2026)
- K252730: Fule Spinal Fixation System (Oct 24, 2025)

Source page: https://510kreport.com/company/beijing-fule-science-technology-development