K231340
- 510(k) number
- K231340
- Device name
- Renova Spine Balloon Catheter
- Applicant
- Biopsybell S.R.L. IT
- Product code
- NDN — Cement, Bone, Vertebroplasty
- Decision date
- 2023-10-30
- Date received
- 2023-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231340.pdf
Official FDA record: K231340
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.