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 |