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

    CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM

    K Number: K080860 · Decision May 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM
    K Number
    K080860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Creaspine
    Date Received
    March 27, 2008
    Decision Date
    May 29, 2008
    Product Code
    MQP
    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
    MQP Spinal Vertebral Body Replacement Device

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    Other Clearances by Creaspine

    K Number Device Name
    K081564 CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION