FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Fule Spinal Fixation System
K Number: K252730
·
Decision Oct 24, 2025
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
3
Review Days
57
Basic Information
- Device Name
- Fule Spinal Fixation System
- K Number
- K252730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd.
- Date Received
- August 28, 2025
- Decision Date
- October 24, 2025
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKB), ordered by most recent decision date.
Socko Vimax Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ChanPin Pedicle Screw Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Varion Thoracolumbar Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
FDA 510(k)
FDA Class 2
·Orthopedic
AccelFix Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
PERLA® TL Posterior Thoraco-lumbar Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic