K053445 is an FDA 510(k) clearance for the SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 6, 2006, 25 days after receiving the submission on December 12, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K053445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2005 |
| Decision Date | January 06, 2006 |
| Days to Decision | 25 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 |