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

    AlignMATE™ Lapidus Arthrodesis System

    K Number: K162391 · Decision Feb 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    26
    Review Days
    179

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    Basic Information

    Device Name
    AlignMATE™ Lapidus Arthrodesis System
    K Number
    K162391
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arthrosurface, Inc.
    Date Received
    August 26, 2016
    Decision Date
    February 21, 2017
    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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