The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Vertecem.
| Device ID | K090435 |
| 510k Number | K090435 |
| Device Name: | VERTECEM |
| 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 | 2009-02-19 |
| Decision Date | 2009-12-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VERTECEM 78531666 not registered Dead/Abandoned |
SYNTHES (U.S.A.) 2004-12-13 |
![]() VERTECEM 77638101 3944858 Live/Registered |
DEPUY SYNTHES, INC. 2008-12-22 |