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

    AMT POLYAXIAL PEDICLE SCREW

    K Number: K022768 · Decision Nov 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    AMT POLYAXIAL PEDICLE SCREW
    K Number
    K022768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micron Precision Engineering, Inc.
    Date Received
    August 21, 2002
    Decision Date
    November 13, 2002
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

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