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Found 5 results
510(k) Data Aggregation
K Number
K183666Device Name
EBA One Nailing System
Manufacturer
CITIEFFE S.r.l.
Date Cleared
2019-11-14
(322 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
CITIEFFE S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions.
EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.
Device Description
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K Number
K181540Device Name
Estremo Citieffe Nailing System
Manufacturer
CITIEFFE S.r.L.
Date Cleared
2019-01-16
(219 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
CITIEFFE S.r.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following:
- · diaphyseal femoral fractures;
- · supra-condylar femoral fractures:
- · corrective osteotomies;
- · pseudoarthrosis:
- non-unions and mal-unions.
The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following:
- · diaphyseal tibial fractures;
- · corrective osteotomies;
- · pseudoarthrosis;
- · non-unions and mal-unions.
The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal arthrodesis.
Device Description
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K Number
K180150Device Name
PL8 Wrist Reconstruction Plate
Manufacturer
CITIEFFE S.r.l.
Date Cleared
2018-08-02
(195 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
CITIEFFE S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PL8 Wrist Reconstruction Plate is indicated for the treatment of intra-articular and extra-articular fractures and osteotomies of the distal radius.
Device Description
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K Number
K132363Device Name
DOLPHIX EXTERNAL FIXATION SYSTEM
Manufacturer
CITIEFFE S.R.L.
Date Cleared
2014-01-16
(170 days)
Product Code
KTT, JDW
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
CITIEFFE S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods. Dolphix® External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries; -
- Temporary stabilization of fractures in the context of polytrauma: -
- Temporary stabilization of certain pelvic fractures or pelvic ring injuries; ...
- Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure;
- Temporary stabilization of non-unions; -
- Intra-operative temporary stabilization tool to assist with indirect reduction. -
Dolphix® External Fixation System is intended for use in a non-weight bearing patient.
Device Description
Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods.
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K Number
K131005Device Name
EBA2 FEMORAL NAILING SYSTEM
Manufacturer
CITIEFFE S.R.L.
Date Cleared
2013-06-25
(75 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
CITIEFFE S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EBA2 Femoral Nailing System is intended for insertion into the medullary canal of femur for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: tractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
Device Description
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