Beijing Fule Science & Technology Development Co., Ltd.
Beijing, CN
BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. appears in FDA device records in Beijing, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Beijing Fule Science & Technology Development Co., Ltd. between 2025 and 2026. The busiest year on record is 2026, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | HSB | Substantially Equivalent | |
| K253151 | Fule Interbody Fusion Cage System | MAX | Substantially Equivalent | |
| K252730 | Fule Spinal Fixation System | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3038195984 | 3038195984 | BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. | No.50, Mafang West Industry Zone, Pinggu District, Beijing, China., Beijing 101204 CN | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWJAwl
- HXWBender
- HTWBit, Drill
- HTTBurr, Orthopedic
- GEACannula, Surgical, General & Plastic Surgery
- HTFCurette
- HXZCutter, Wire
- GDIDissector, Surgical, General & Plastic Surgery
- HTJGauge, Depth
- GDFGuide, Needle, Surgical
- FZYHammer, Surgical
- GDZHandle, Scalpel
- HXKHolder, Needle; Orthopedic
- KIKHook, Bone
- HWAImpactor
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- HXPInstrument, Bending Or Contouring
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- HWMOsteotome
- HTCPliers, Surgical
- KILPositioner, Socket
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HTXRongeur
- GDRSaw, Manual And Accessories
- HRRScissors, Orthopedic, Surgical
- OCJSpinal Channeling Instrument, Vertebroplasty
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- HWKTrephine
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain