LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    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.
    Ask a Question
    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.
    Ask a Question

    Page 1 of 1