The following data is part of a premarket notification filed by Teknimed, Sas with the FDA for High V+.
| Device ID | K161114 |
| 510k Number | K161114 |
| Device Name: | HIGH V+ |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Teknimed, SAS 11, Rue D'Apollo L'union, FR 31240 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-20 |
| Decision Date | 2017-04-12 |
| Summary: | summary |