Data / Medical devices / Italy / Citieffe SRL
Citieffe SRL: FDA-registered device maker in Calderara di Reno Bologna, Italy, 11 510(k) clearances
Citieffe SRL is registered with the FDA (registration 3003249380) in Calderara di Reno Bologna, Italy. It lists 13 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003249380
- Address
- Via Armaroli 21, Calderara di Reno Bologna, Italy, 40012
- Owner or operator
- Citieffe srl (10040297)
- Roles
- Manufacturer
- First device listed
- March 29, 2012
- Registered through
- 2026
- Brand names listed
- Citieffe Cannulated Screw (Pin) RONDO¿, Citieffe External Fixator ST.A.R. 90 F4 ELBOW, Citieffe External Fixator ST.A.R. 90 F4 KNEE, DOLPHIX® EX.FIX.SYS. MR CONDITIONAL, DOLPHIX® EXTERNAL FIXATION SYSTEM, Dinamic T, Dolphix External Fixation System, Dolphix® External Fixation System MR Conditional and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2025 | K250197 | Estremo Fibular Nail | HSB | Substantially Equivalent | Citieffe S.R.L. | accessdata.fda.gov |
| November 14, 2019 | K183666 | EBA One Nailing System | HSB | Substantially Equivalent | Citieffe S.R.L. | accessdata.fda.gov |
| January 16, 2019 | K181540 | Estremo Citieffe Nailing System | HSB | Substantially Equivalent | Citieffe S.R.L. | accessdata.fda.gov |
| August 2, 2018 | K180150 | PL8 Wrist Reconstruction Plate | HRS | Substantially Equivalent | Citieffe S.R.L. | accessdata.fda.gov |
| March 20, 2017 | K163323 | Dolphix® External Fixation System MR Conditional | KTT | Substantially Equivalent | Citieffe S.R.L. | accessdata.fda.gov |
| July 7, 2015 | K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | JDW | Substantially Equivalent | Citieffe S.R.L. | accessdata.fda.gov |
| January 16, 2014 | K132363 | DOLPHIX EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Citieffe S.R.L. | accessdata.fda.gov |
| June 25, 2013 | K131005 | EBA2 FEMORAL NAILING SYSTEM | HSB | Substantially Equivalent | Citieffe S.R.L. | accessdata.fda.gov |
| June 5, 2012 | K113388 | CITIEFFE-TITANIUM CANNULATED SCREW | HWC | Substantially Equivalent | Citieffe | accessdata.fda.gov |
| May 1, 2012 | K113384 | EXTERNAL FIXATOR ST.A R 90 F4 | KTT | Substantially Equivalent | Citieffe | accessdata.fda.gov |
| March 15, 2012 | K113387 | CITIEFFE TITANIUM NAILING SYSTEM | HSB | Substantially Equivalent | Citieffe | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Bit, Drill
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Pin, Fixation, Threaded
- All makers of Orthopedic Manual Surgical Instrument
Updated October 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.