The following data is part of a premarket notification filed by Immedica, Inc. with the FDA for Concert Radiopaque Bone Cement.
| Device ID | K013755 |
| 510k Number | K013755 |
| Device Name: | CONCERT RADIOPAQUE BONE CEMENT |
| Classification | Bone Cement |
| Applicant | IMMEDICA, INC. 615 7TH ST. NE Washington, DC 20002 |
| Contact | Russell Pagano |
| Correspondent | Russell Pagano IMMEDICA, INC. 615 7TH ST. NE Washington, DC 20002 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-02-08 |