Device Classification Name |
cement, bone, vertebroplasty
|
510(k) Number |
K191709 |
Device Name |
V-STRUT Vertebral Implant |
Applicant |
Hyprevention SAS |
PTIB - Hopital Xavier Arnozan - Avenue du Haut-Leveque |
pessac cedex,
FR
33604
|
|
Applicant Contact |
cecile vienney |
Correspondent |
Hyprevention SAS |
PTIB - Hopital Xavier Arnozan - Avenue du Haut-Leveque |
pessac cedex,
FR
33604
|
|
Correspondent Contact |
cecile vienney |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2019 |
Decision Date | 03/05/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|