K043518 is an FDA 510(k) clearance for the RADIOPAQUE BONE CEMENT. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on May 11, 2005, 142 days after receiving the submission on December 20, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K043518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2004 |
| Decision Date | May 11, 2005 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN — Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |