The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Opacity + Bone Cement.
| Device ID | K080873 |
| 510k Number | K080873 |
| Device Name: | OPACITY + BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-08-28 |
| Summary: | summary |