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510(k) Data Aggregation

    K Number
    K202858
    Device Name
    Flex-ThreadTM Distal Fibula Intramedullary Nail System
    Manufacturer
    Conventus Orthopaedics, LLC
    Date Cleared
    2021-01-22

    (116 days)

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

    Conventus Orthopaedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.
    Device Description
    The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.
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    K Number
    K161048
    Device Name
    Conventus Orthopaedics Ulna Fixation System
    Manufacturer
    CONVENTUS ORTHOPAEDICS, INC.
    Date Cleared
    2016-07-26

    (103 days)

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

    CONVENTUS ORTHOPAEDICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conventus Orthopaedics Ulna Fixation System is indicated for treatment of distal or proximal ulna fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.
    Device Description
    The Conventus Orthopaedics Ulna Fixation System is an intramedullary device intended for distal and proximal ulna fractures. The Ulna Fixation System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.
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    K Number
    K151379
    Device Name
    Conventus PRS System
    Manufacturer
    Conventus Orthopaedics, Inc
    Date Cleared
    2015-08-13

    (83 days)

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

    Conventus Orthopaedics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conventus PRSTM System is indicated for treatment of proximal radial fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.
    Device Description
    The Conventus PRSTM is an intramedullary device intended for proximal radius fractures. The PRSTM System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.
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    K Number
    K141737
    Device Name
    CONVENTUS PHS SYSTEM
    Manufacturer
    CONVENTUS ORTHOPAEDICS, INC.
    Date Cleared
    2015-04-08

    (285 days)

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

    CONVENTUS ORTHOPAEDICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conventus Orthopaedics PHS™ System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.
    Device Description
    The Conventus PHS™ is an intramedullary device intended to treat proximal humerus fractures. The PHS™ System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.
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    K Number
    K131552
    Device Name
    CONVENTUS DRS
    Manufacturer
    CONVENTUS ORTHOPAEDICS
    Date Cleared
    2014-02-12

    (258 days)

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

    CONVENTUS ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conventus DRSTM is intended for the fixation of distal radius fractures.
    Device Description
    The Conventus DRSTM is an intramedullary device intended to treat distal radius fractures. The DRS is comprised of an Expandable Scaffold, Fragment Screws, and a Proximal Plate. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti6Al4V) and Nitinol.
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    K Number
    K102689
    Device Name
    CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM
    Manufacturer
    CONVENTUS ORTHOPAEDICS
    Date Cleared
    2013-01-17

    (853 days)

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

    CONVENTUS ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conventus DRS™ is intended for use in the fixation of fractures of the distal radius.
    Device Description
    The Conventus DRSTM is an intramedullary device intended to treat distal radius fractures. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti-6Al-4V) and Nitinol.
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