K000943 is an FDA 510(k) clearance for the CEMEX SYSTEM GUN APPLICATION VERSION. 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 February 8, 2001, 322 days after receiving the submission on March 23, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K000943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2000 |
| Decision Date | February 08, 2001 |
| Days to Decision | 322 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 |