Citieffe S.R.L. is one of 16117 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Citieffe S.R.L. - FDA 510(k) Cleared Devices
Recent clearances: Estremo Fibular Nail, EBA One Nailing System, Estremo Citieffe Nailing System
8
Total
8
Cleared
0
Denied
Citieffe S.R.L. has 8 FDA 510(k) cleared medical devices. Based in Ormond Beach, US.
Latest FDA clearance: Oct 2025. Active since 2013. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Citieffe S.R.L. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by THEMA S.r.l. and Thelma S.R.L.
FDA 510(k) Regulatory Record - Citieffe S.R.L.
8 devices
Cleared
Oct 17, 2025
Estremo Fibular Nail
Orthopedic
267d
Cleared
Nov 14, 2019
EBA One Nailing System
Orthopedic
322d
Cleared
Jan 16, 2019
Estremo Citieffe Nailing System
Orthopedic
219d
Cleared
Aug 02, 2018
PL8 Wrist Reconstruction Plate
Orthopedic
195d
Cleared
Mar 20, 2017
Dolphix® External Fixation System MR Conditional
Orthopedic
115d
Cleared
Jul 07, 2015
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
Orthopedic
116d
Cleared
Jan 16, 2014
DOLPHIX EXTERNAL FIXATION SYSTEM
Orthopedic
170d
Cleared
Jun 25, 2013
EBA2 FEMORAL NAILING SYSTEM
Orthopedic
75d