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

    Revolution Radial Head

    K Number: K183618 · Decision May 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    142

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    Basic Information

    Device Name
    Revolution Radial Head
    K Number
    K183618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3170
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ignite Orthopedics, Inc.
    Date Received
    December 26, 2018
    Decision Date
    May 17, 2019
    Product Code
    KWI
    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
    KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

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