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510(k) Data Aggregation

    K Number
    K183666
    Device Name
    EBA One Nailing System
    Manufacturer
    Date Cleared
    2019-11-14

    (322 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Not Found
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    K Number
    K181540
    Device Name
    Estremo Citieffe Nailing System
    Manufacturer
    Date Cleared
    2019-01-16

    (219 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    K180150
    Device Name
    PL8 Wrist Reconstruction Plate
    Manufacturer
    Date Cleared
    2018-08-02

    (195 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Not Found
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    K Number
    K163323
    Device Name
    Dolphix® External Fixation System MR Conditional
    Manufacturer
    Date Cleared
    2017-03-20

    (115 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE s

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods. Dolphix® External Fixation System MR Conditional 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 MR Conditional is intended for use in a non-weight bearing patient.
    Device Description
    Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods.
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    K Number
    K150661
    Device Name
    ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
    Manufacturer
    Date Cleared
    2015-07-07

    (116 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE s

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Citieffe External Fixator ST.A.R 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include: - Fracture dislocation with ligaments instability; - Comminuted intra-articular fractures; - Post traumatic reconstruction for joint stiffness. Citieffe External Fixator ST.AR. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
    Device Description
    ST.A.R.90 F4 External Fixation Screws With Hydroxyapatite
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    K Number
    K132363
    Device Name
    DOLPHIX EXTERNAL FIXATION SYSTEM
    Manufacturer
    Date Cleared
    2014-01-16

    (170 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    K131005
    Device Name
    EBA2 FEMORAL NAILING SYSTEM
    Manufacturer
    Date Cleared
    2013-06-25

    (75 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Not Found
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    K Number
    K113388
    Device Name
    CITIEFFE-TITANIUM CANNULATED SCREW
    Manufacturer
    Date Cleared
    2012-06-05

    (202 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Citieffe Rondò Cannulated Screw is intended for fracture fixation of small and long bones and pelvis. The system is not intended for spinal use.
    Device Description
    Not Found
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    K Number
    K113384
    Device Name
    EXTERNAL FIXATOR ST.A R 90 F4
    Manufacturer
    Date Cleared
    2012-05-01

    (167 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Citieffe External Fixator ST.A.R. 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include: - Fracture dislocation with ligaments instability; - Comminuted intra-articular fractures; l - Post traumatic reconstruction for joint stiffness. All blanks are sold by or on the order of a physician. They are not for use by the general public or over-the-counter. Citieffe External Fixator ST.A.R. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. All blanks are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.
    Device Description
    Not Found
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    K Number
    K113387
    Device Name
    CITIEFFE TITANIUM NAILING SYSTEM
    Manufacturer
    Date Cleared
    2012-03-15

    (120 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    CITIEFFE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Citieffe Titanium Nailing System is intended for insertion into the medullary canal of a specific long bone – humerus and femur -for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
    Device Description
    Citieffe Titanium Nailing System
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