FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Kyphoplasty Balloon Dilatation Catheters
K Number: K252458
·
Decision Nov 3, 2025
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
1
Review Days
90
Basic Information
- Device Name
- Kyphoplasty Balloon Dilatation Catheters
- K Number
- K252458
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai Lange Medtech Co., Ltd.
- Date Received
- August 5, 2025
- Decision Date
- November 3, 2025
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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