BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MultiFIX S Ultra Knotless Fixation System

    K Number: K153669 · Decision Jan 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    MultiFIX S Ultra Knotless Fixation System
    K Number
    K153669
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arthocare Corporation
    Date Received
    December 21, 2015
    Decision Date
    January 19, 2016
    Product Code
    MBI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Arthocare Corporation

    K Number Device Name
    K131182 MULTIFIX S KNOTLESS FIXATION DEVICE
    K120791 AMBIENT TURBOFLASH 90 IFS
    K123268 SMARTSTITCH PERFECTPASSER SYSTEM
    K121306 SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
    K013334 ENDOFLIP