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

    NewPrim System

    K Number: K191966 · Decision Feb 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    20
    Applicant Total
    2
    Review Days
    205

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    Basic Information

    Device Name
    NewPrim System
    K Number
    K191966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3720
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brm Extremities
    Date Received
    July 23, 2019
    Decision Date
    February 13, 2020
    Product Code
    KWH
    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
    KWH Prosthesis, Toe, Constrained, Polymer

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