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

    SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X

    K Number: K041989 · Decision Sep 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    655
    Applicant Total
    10
    Review Days
    55

    Basic Information

    Device Name
    SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
    K Number
    K041989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SINTEA BIOTECH, INC.
    Date Received
    July 23, 2004
    Decision Date
    September 16, 2004
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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