The following data is part of a premarket notification filed by Hyprevention Sas with the FDA for V-strut Vertebral Implant.
| Device ID | K191709 |
| 510k Number | K191709 |
| Device Name: | V-STRUT Vertebral Implant |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Hyprevention SAS PTIB - Hopital Xavier Arnozan - Avenue Du Haut-Leveque Pessac Cedex, FR 33604 |
| Contact | Cecile Vienney |
| Correspondent | Cecile Vienney Hyprevention SAS PTIB - Hopital Xavier Arnozan - Avenue Du Haut-Leveque Pessac Cedex, FR 33604 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2020-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03770007907417 | K191709 | 000 |
| 03770007907332 | K191709 | 000 |
| 03770007907349 | K191709 | 000 |
| 03770007907356 | K191709 | 000 |
| 03770007907363 | K191709 | 000 |
| 03770007907370 | K191709 | 000 |
| 03770007907387 | K191709 | 000 |
| 03770007907394 | K191709 | 000 |
| 03770007907400 | K191709 | 000 |
| 03770007907325 | K191709 | 000 |