The following data is part of a premarket notification filed by G21 S.r.l. with the FDA for V-steady, V-fast.
| Device ID | K150408 |
| 510k Number | K150408 |
| Device Name: | V-STEADY, V-FAST |
| Classification | Bone Cement |
| Applicant | G21 S.R.L. VIA SANDRO PERTINI, 8 San Possidonio, IT 41039 |
| Contact | Maurizio Foroni |
| Correspondent | Maurizio Foroni G21 S.r.l. VIA S. Pertini San Possidonio(mo), IT 841039 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-12-14 |
| Summary: | summary |