K014199 is an FDA 510(k) clearance for the SURGICAL SIMPLEX P WITH TOBRAMYCIN. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on May 6, 2003, 501 days after receiving the submission on December 21, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K014199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2001 |
| Decision Date | May 06, 2003 |
| Days to Decision | 501 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 |