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

    QUANTUM ANTERIOR CERVICAL PLATE SYSTEM

    K Number: K060491 · Decision Mar 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    5
    Review Days
    17

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    Basic Information

    Device Name
    QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
    K Number
    K060491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantum Orthopedics, Inc.
    Date Received
    February 24, 2006
    Decision Date
    March 13, 2006
    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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    Other Clearances by Quantum Orthopedics, Inc.

    K Number Device Name
    K062004 MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
    K061576 MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
    K052641 MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT
    K050449 QUANTUM VERTEBRAL BODY REPLACEMENT