K043403 is an FDA 510(k) clearance for the CEMEX SYSTEM GENTA FAST BONE CEMENT. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on December 28, 2004, 18 days after receiving the submission on December 10, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K043403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2004 |
| Decision Date | December 28, 2004 |
| Days to Decision | 18 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 |