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

    SUBTALAR PEG IMPLANT

    K Number: K033046 · Decision Dec 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    16
    Review Days
    85

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    Basic Information

    Device Name
    SUBTALAR PEG IMPLANT
    K Number
    K033046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nexa Orthopedics, Inc.
    Date Received
    September 29, 2003
    Decision Date
    December 23, 2003
    Product Code
    MJW
    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
    MJW Prosthesis, Subtalar, Plug, Polymer

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