K063857 is an FDA 510(k) clearance for the SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT. This device is classified as a Bone Cement, Antibiotic (Class II - Special Controls, product code MBB).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on February 26, 2007, 60 days after receiving the submission on December 28, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K063857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2006 |
| Decision Date | February 26, 2007 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| 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 |