FDA Registration
Active
🇮🇹 Italy
CITIEFFE SRL
Reg #: 3003249380
·
FEI: 3003249380
·
Expires 2026
Products
13
Proprietary Names
32
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- CITIEFFE SRL
- Registration Number
- 3003249380
- FEI Number
- 3003249380
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Armaroli 21
- City
- Calderara di Reno Bologna
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K132363
Owner / Operator
- Firm Name
- Citieffe srl
- Operator Number
- 10040297
- Address
- Via Armaroli 21
- City
- Calderara di Reno
- State
- Bologna
- Postal Code
- 40012
- Country
- IT
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wrench | HXC | Class 1 | Orthopedic | No | 2021-12-22 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2014-01-21 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2014-01-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-12-22 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2021-12-22 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2025-12-11 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2022-06-28 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-08-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-06-11 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2021-12-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-04-15 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-06-29 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2021-12-22 |
Proprietary Names
ORTHOPAEDIC SURGICAL INSTRUMENTS
Dolphix External Fixation System
DOLPHIX® EXTERNAL FIXATION SYSTEM
ESTREMO FIBULAR NAIL
EBA-1700 Endovis B.A. long nail RIGHT
EBA-1800 Endovis B.A. long nail RIGHT
Dinamic T
EBA-1750 Endovis B.A. long nail LEFT
EBA-1500 Endovis B.A. medium nail
TITANIUM NAILING SYSTEM
EBA-1100 Endovis B.A. standard nail
EBA-1850 Endovis B.A. long nail LEFT
EBA-1950 Endovis B.A. long nail LEFT
EBA-1900 Endovis B.A. long nail RIGHT
PL8 Wrist Reconstruction Plate
PL8 WRIST RECONSTRUCTION PLATE
Citieffe External Fixator ST.A.R. 90 F4 KNEE
Citieffe External Fixator ST.A.R. 90 F4 ELBOW
ST.A.R. 90 F4 External Fixator
EBA2 Femoral Nailing System
EBA2 NAILING SYSTEM
Estremo Citieffe Nailing System
ESTREMO CITIEFFE NAILING SYSTEM
Dolphix® External Fixation System MR Conditional
DOLPHIX® EX.FIX.SYS. MR CONDITIONAL
RONDO' CANNULATED SCREW
Citieffe Cannulated Screw (Pin) RONDO¿
EBA ONE NAILING SYSTEM
EBA One Nailing System
ST.A.R.90 F4 External Fixation Screws with Hydroxyapatite
ST.A.R. 90 F4 EXT.FIX. SCREWS WITH HA
External Fixation Screws with Hydroxyapatite
Establishment Types
Manufacture Medical Device