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

    VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

    K Number: K212581 · Decision Jan 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    54
    Review Days
    156

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    Basic Information

    Device Name
    VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
    K Number
    K212581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker GmbH
    Date Received
    August 16, 2021
    Decision Date
    January 19, 2022
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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