K211163 is an FDA 510(k) clearance for the Bone Cement Genta, Bone Cement HV, Bone Cement LV. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Tecres S.P.A. (Sommacampagna, IT). The FDA issued a Cleared decision on January 9, 2023, 630 days after receiving the submission on April 19, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K211163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2021 |
| Decision Date | January 09, 2023 |
| Days to Decision | 630 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LOD - Bone Cement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |