K191709 is an FDA 510(k) clearance for the V-STRUT Vertebral Implant. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Hyprevention Sas (Pessac Cedex, FR). The FDA issued a Cleared decision on March 5, 2020, 253 days after receiving the submission on June 26, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K191709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2019 |
| Decision Date | March 05, 2020 |
| Days to Decision | 253 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 |