The following data is part of a premarket notification filed by Citieffe S.r.l. with the FDA for Estremo Citieffe Nailing System.
| Device ID | K181540 |
| 510k Number | K181540 |
| Device Name: | Estremo Citieffe Nailing System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | CITIEFFE S.r.L. Via Armaroli, 21 Calderara Di Reno, IT 40012 |
| Contact | Stefano Pullega |
| Correspondent | Stefano Pullega CITIEFFE S.r.L. Via Armaroli, 21 Calderara Di Reno, IT 40012 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2019-01-16 |