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 |