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 |