K231340 is an FDA 510(k) clearance for the Renova Spine Balloon Catheter. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Biopsybell S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on October 30, 2023, 174 days after receiving the submission on May 9, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K231340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2023 |
| Decision Date | October 30, 2023 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN - Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |