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

    CAVUX CervicalCage-L SA System

    K Number: K163474 · Decision Mar 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    21
    Review Days
    88

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    Basic Information

    Device Name
    CAVUX CervicalCage-L SA System
    K Number
    K163474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Providence Medical Technology, Inc.
    Date Received
    December 12, 2016
    Decision Date
    March 10, 2017
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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    Other Clearances by Providence Medical Technology, Inc.

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    K240625 CORUS Navigation Access System
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