The following data is part of a premarket notification filed by Globus Medical, Inc with the FDA for Concord Radiopaque Bone Cement.
| Device ID | K042168 |
| 510k Number | K042168 |
| Device Name: | CONCORD Radiopaque Bone Cement |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Globus Medical, Inc 2560 General Armistead Avenue Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker Globus Medical, Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2005-01-14 |
| Summary: | summary |