The following data is part of a premarket notification filed by Teknimed, S.a.s. with the FDA for Cohesion Bone Cement.
| Device ID | K103816 |
| 510k Number | K103816 |
| Device Name: | COHESION BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | TEKNIMED, S.A.S. 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J. D Webb |
| Correspondent | J. D Webb TEKNIMED, S.A.S. 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 | 2010-12-29 |
| Decision Date | 2011-02-04 |
| Summary: | summary |