Device Classification Name |
cement, bone, vertebroplasty
|
510(k) Number |
K161114 |
Device Name |
HIGH V+ |
Applicant |
Teknimed, SAS |
11, Rue d'Apollo |
L'Union,
FR
31240
|
|
Applicant Contact |
J.D. Webb |
Correspondent |
The OrthoMedix Group, Inc. |
1001 Oakwood Blvd |
Round Rock,
TX
78681
|
|
Correspondent Contact |
J.D. Webb |
Regulation Number | 888.3027
|
Classification Product Code |
|
Date Received | 04/20/2016 |
Decision Date | 04/12/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|