Beijing Fule Science & Technology Development Co., Ltd.
Registered establishment in Beijing, China. 31 device types, 4 clearances.
Beijing Fule Science & Technology Development Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Awl, Bender and 29 other device types. Its earliest product listing with the FDA dates from 2025.
31device types registered with the FDA
4510(k) clearances
Registration
| Registered name | BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3038195984 |
| FEI number | 3038195984 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 北京市富乐科技开发有限公司 |
|---|---|
| Unified social credit code | 91110117102618418H |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | No.50, Mafang West Industry Zone, Pinggu District, Beijing, China. |
| Postal code | 101204 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Awl | Class 1 | 2025 | 13 |
| Bender | Class 1 | 2025 | 10 |
| Bit, Drill | Class 1 | 2025 | 27 |
| Burr, Orthopedic | Class 1 | 2025 | 3 |
| Cannula, Surgical, General & Plastic Surgery | Class 1 | 2025 | 14 |
| Curette | Class 1 | 2025 | 11 |
| Cutter, Wire | Class 1 | 2025 | 10 |
| Dissector, Surgical, General & Plastic Surgery | Class 1 | 2025 | 14 |
| Gauge, Depth | Class 1 | 2025 | 14 |
| Guide, Needle, Surgical | Class 1 | 2025 | 32 |
| Hammer, Surgical | Class 1 | 2025 | 20 |
| Handle, Scalpel | Class 1 | 2025 | 29 |
| Holder, Needle; Orthopedic | Class 1 | 2025 | 15 |
| Hook, Bone | Class 1 | 2025 | 3 |
| Impactor | Class 1 | 2025 | 18 |
| Injector, Vertebroplasty (Does Not Contain Cement) | Class 1 | 2025 | 5 |
| Instrument, Bending Or Contouring | Class 1 | 2025 | 5 |
| Orthopedic Manual Surgical Instrument | Class 1 | 2025 | 53 |
| Osteotome | Class 1 | 2025 | 9 |
| Pliers, Surgical | Class 1 | 2025 | 11 |
| Positioner, Socket | Class 1 | 2025 | 4 |
| Reamer | Class 1 | 2025 | 23 |
| Retractor | Class 1 | 2025 | 34 |
| Rongeur | Class 1 | 2025 | 11 |
| Saw, Manual And Accessories | Class 1 | 2025 | 4 |
| Scissors, Orthopedic, Surgical | Class 1 | 2025 | 6 |
| Spinal Channeling Instrument, Vertebroplasty | Class 1 | 2025 | 5 |
| Tap, Bone | Class 1 | 2025 | 12 |
| Template | Class 1 | 2025 | 21 |
| Trephine | Class 1 | 2025 | 6 |
| Wrench | Class 1 | 2025 | 14 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260203 | 2026-08-28 | HRX | Traditional | This company |
| K253155 | 2026-06-17 | HSB | Traditional | This company |
| K253151 | 2026-06-15 | MAX | Traditional | This company |
| K252730 | 2025-10-24 | NKB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | Spinal Screw-Rod Systems, Minimal Invasive Spinal System, Cervical Bone Plate System, Locking Plate Systems, External fixation systems |
| Certifications | ISO, TUV NAF, MDSAP |
| Export markets | Czech Republic, France, Russia, Egypt, Turkey, Saudi Arabia |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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