K252458
- 510(k) number
- K252458
- Device name
- Kyphoplasty Balloon Dilatation Catheters
- Applicant
- Shanghai Lange Medtech Co., Ltd. CN
- Product code
- HRX — Arthroscope
- Decision date
- 2025-11-03
- Date received
- 2025-08-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252458.pdf
Official FDA record: K252458
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.