K242216 is an FDA 510(k) clearance for the GENTAFIX® (1, 3, 3MV). This device is classified as a Bone Cement, Antibiotic (Class II - Special Controls, product code MBB).
Submitted by Teknimed Sas (L'Union, FR). The FDA issued a Cleared decision on December 18, 2024, 142 days after receiving the submission on July 29, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K242216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2024 |
| Decision Date | December 18, 2024 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBB - Bone Cement, Antibiotic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |