K232842
- 510(k) number
- K232842
- Device name
- Balloon Inflation System
- Applicant
- Ningbo Hicren Biotechnology Co., Ltd. CN
- Product code
- NDN — Cement, Bone, Vertebroplasty
- Decision date
- 2024-02-29
- Date received
- 2023-09-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232842.pdf
Official FDA record: K232842
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.