K053002 is an FDA 510(k) clearance for the DEPUY CMW 1 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 November 22, 2005, 27 days after receiving the submission on October 26, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K053002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2005 |
| Decision Date | November 22, 2005 |
| Days to Decision | 27 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 |