FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Fule Metallic Lockable Intramedullary Nail Systems
K Number: K253155
·
Decision Jun 17, 2026
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
3
Review Days
264
Basic Information
- Device Name
- Fule Metallic Lockable Intramedullary Nail Systems
- K Number
- K253155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd.
- Date Received
- September 26, 2025
- Decision Date
- June 17, 2026
- Product Code
- HSB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSB), ordered by most recent decision date.
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
FDA 510(k)
FDA Class 2
·Orthopedic
Precice Max System and Precice Ankle Salvage System
FDA 510(k)
FDA Class 2
·Orthopedic
HERA Interlocking Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOBAHN Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic