Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003249380

FEI Number

3003249380

Entity Name

CITIEFFE SRL

City/State/Country

Calderara di Reno Bologna, IT

Establishment Address

Via Armaroli 21, Calderara di Reno Bologna 40012, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Citieffe srl (Owner Number: 10040297)

Owner / Operator Contact Address

Via Armaroli 21, Calderara di Reno, IT-BO 40012, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOPAEDIC SURGICAL INSTRUMENTS Dolphix External Fixation System DOLPHIX® EXTERNAL FIXATION SYSTEM ORTHOPAEDIC SURGICAL INSTRUMENTS ORTHOPAEDIC SURGICAL INSTRUMENTS 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 ORTHOPAEDIC SURGICAL INSTRUMENTS 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¿ ORTHOPAEDIC SURGICAL INSTRUMENTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXC	Wrench	Orthopedic	Class 1	888.4540	2021-12-22
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2014-01-21
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2014-01-21
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2021-12-22
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2021-12-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-12-11
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2012-03-29
HTO	Reamer	Orthopedic	Class 1	888.4540	2022-06-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-08-07
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2012-05-08
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-05-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-06-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-01-22
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2017-03-21
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2017-03-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-11
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2021-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

Citieffe srl

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003249380. Last updated year: 2026. Please use registration number 3003249380 when referencing this establishment in official correspondence.