K033382 is an FDA 510(k) clearance for the SMARTSET GMV ENDURANCE GENTAMICIN 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 February 5, 2004, 105 days after receiving the submission on October 23, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K033382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2003 |
| Decision Date | February 05, 2004 |
| Days to Decision | 105 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 |