The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Concord Plus Radiopaque Bone Cement.
| Device ID | K162618 |
| 510k Number | K162618 |
| Device Name: | CONCORD Plus Radiopaque Bone Cement |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. 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 | 2016-09-20 |
| Decision Date | 2017-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095358247 | K162618 | 000 |
| 00889095358230 | K162618 | 000 |