K092773 is an FDA 510(k) clearance for the CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on November 24, 2009, 76 days after receiving the submission on September 9, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K092773 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2009 |
| Decision Date | November 24, 2009 |
| Days to Decision | 76 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LOD - Bone Cement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |