The following data is part of a premarket notification filed by Vexim Sa with the FDA for Spinejack Expansion Kit.
| Device ID | K181262 |
| 510k Number | K181262 |
| Device Name: | SpineJack Expansion Kit |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Vexim SA 8 Rue Vidailhan Balma, FR 31130 |
| Contact | Vincent Gardes |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-11 |
| Decision Date | 2018-08-30 |
| Summary: | summary |