K053198 is an FDA 510(k) clearance for the SIMPLEX P SPEEDSET BONE CEMENT. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on January 26, 2006, 71 days after receiving the submission on November 16, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K053198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2005 |
| Decision Date | January 26, 2006 |
| Days to Decision | 71 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 |