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

    MODIFICATION OF TSRH SPINAL SYSTEM

    K Number: K984522 · Decision Jan 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    56
    Review Days
    16

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    Basic Information

    Device Name
    MODIFICATION OF TSRH SPINAL SYSTEM
    K Number
    K984522
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Danek Medical, Inc.
    Date Received
    December 21, 1998
    Decision Date
    January 6, 1999
    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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