K030086 is an FDA 510(k) clearance for the PALACOS R BONE CEMENT WITH GENTAMICIN. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 17, 2003, 342 days after receiving the submission on January 9, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K030086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2003 |
| Decision Date | December 17, 2003 |
| Days to Decision | 342 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 |