K081163 is an FDA 510(k) clearance for the SMARTSET GMV GENTAMICIN BONE CEMENT. This device is classified as a Bone Cement, Antibiotic (Class II - Special Controls, product code MBB).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 14, 2008, 20 days after receiving the submission on April 24, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K081163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2008 |
| Decision Date | May 14, 2008 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBB - Bone Cement, Antibiotic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |