K042168 is an FDA 510(k) clearance for the CONCORD Radiopaque Bone Cement. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on January 14, 2005, 158 days after receiving the submission on August 9, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K042168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2004 |
| Decision Date | January 14, 2005 |
| Days to Decision | 158 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 |